CClinicalTrials.gg
Sign In
TerminatedNCT05082012Mini3DUpdated Apr 20, 2026Results posted

Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)

An interventional study of Treatment of Hallux Valgus in Hallux Valgus and Bunion, sponsored by Treace Medical Concepts, Inc.. Terminated at 10 sites in United States. Open to participants aged 14 Years to 58 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by Treace Medical Concepts, Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated
Corporate decision to early term study to prepare for publication and addition of new studies
Phase
Not applicable
Study type
Interventional
Enrollment
123
Allocation
Not applicable
Ages
14 Years to 58 Years
Sex
All
01

Study summary

Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery.

Up to 200 subjects will be treated in this study at up to 20 clinical sites. Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.

Read the detailed description

Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery:

  1. To determine radiographic recurrence of hallux valgus and the timing of failure following hallux valgus correction with the Lapiplasty® Procedure.
  2. To determine whether the Lapiplasty® Procedure effectively corrects anatomical alignment of the 1st metatarsal and sesamoids in all three planes.
  3. To assess whether early weight-bearing after the Lapiplasty® Procedure affects the union rates or causes loss of 3-plane correction.
  4. To evaluate the quality of life and pain scores following the Lapiplasty® Procedure.
02

Conditions studied

  • Hallux Valgus
  • Bunion
03

Who can participate

Ages eligible
14 Years to 58 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Patients satisfying the following criteria will be considered the screening population and will be eligible for participation:

  1. Male and females between the ages 14 and 58 years at the time of consent;
  2. Closed physeal plates at the time of consent;
  3. Intermetatarsal angle is between 10.0˚ - 22.0˚;
  4. Hallux valgus angle is between 16.0˚ - 40.0˚;
  5. Willing and able to adhere to early weight-bearing instructions post-operatively;
  6. Capable of completing self-administered questionnaires;
  7. Acceptable surgical candidate, including use of general anesthesia;
  8. Female patients must be of non-child bearing potential or have a negative pregnancy test within 7 days prior to index procedure;
  9. Willing and able to schedule index procedure within 3 months of consent and able to return for scheduled follow-up visits;
  10. Willing and able to provide written informed consent.

Exclusion criteria

Exclusion Criteria:

Patients satisfying the following criteria will not be eligible for participation:

  1. Previous surgery for hallux valgus on operative side;
  2. Previous surgeries on operative foot involving fusion of foot or ankle joints (other than hammertoe or lesser toes/digits);
  3. Additional concomitant procedures outside of the 1st ray;
  4. Moderate or Severe osteoarthritis of the MTP joint based on radiographic imaging (including lack of evident crista) or positive grind test;
  5. Symptomatic flatfoot or asymptomatic flatfoot (defined as calcaneal inclination \<5˚and talonavicular subluxation/uncovering >50%);
  6. BMI >40 kg/m²;
  7. Current nicotine user, including current use of nicotine patch;
  8. Current clinical diagnosis of diabetes with fasting plasma glucose > 126 mg/dL and/or HbA1c ≥7.0;
  9. Current clinical diagnosis of peripheral neuropathy or by assessment on 4-point monofilament test;
  10. Current clinical diagnosis of fibromyalgia;
  11. Current clinical diagnosis of Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy (CRPS/RSD);
  12. Current uncontrolled hypothyroidism;
  13. Previously sensitized to titanium;
  14. Currently taking oral steroids or rheumatoid biologics;
  15. Currently taking immunosuppressant drugs;
  16. Insufficient quantity or quality of bone to permit stabilization, conditions that retard healing (not including pathological fractures) and conditions causing poor blood supply such as peripheral vascular disease;
  17. Active, suspected or latent infection in the affected area;
  18. Use of synthetic or allogenic bone graft substitutes;
  19. Current diagnosis of metatarsus adductus (defined as MAA ≥ 23˚);
  20. Known keloid and hypertrophic scar forming;
  21. Scheduled to undergo a same-day bilateral procedure. Patient agrees to refrain from the Lapiplasty® Procedure (or other hallux valgus procedures) on contralateral foot for minimum of 6 months post index procedure;
  22. Patient has previously been enrolled into this study for a contralateral procedure;
  23. Scheduled for any concomitant procedure that would alter patient's ability to early weight-bear post-procedure;
  24. Patient requires an incision >4.0 cm to complete the procedure (determined pre-operatively or intra-operatively);
  25. Patient is actively involved with a workman's compensation case or is currently involved in litigation;
  26. Patient is currently or has participated in a clinical study in the last 30 days prior to signing informed consent or is considering participation in another research protocol during this study. Exceptions to this include survey clinical studies with no treatment or if subject is greater than 12 months post procedure in the Treace ALIGN3D™ study without ongoing protocol defined AE; these are not exclusionary;
  27. Patient has a condition or finding that, in the opinion of the Investigator, may jeopardize the patient's well-being, the soundness of this clinical study, or could interfere with provision of informed consent, completion of tests, therapy, or follow-up.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
123 participants (actual)

Interventions

  • DeviceTreatment of Hallux Valgus

    Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on the inclusion/exclusion criteria established in the study protocol. Anticipated subject duration will be 2 years post index procedure.

    Also known as: Lapiplasty® Mini-Incision™ Procedure

05

What researchers measure

Primary outcomes

  1. Radiographic Recurrence

    Radiographic recurrence of hallux valgus deformity at 24 months for subjects with successful correction (defined as Intermetatarsal Angle (IMA) \<9.0°, Hallux Valgus Angle (HVA)\<15.0° and Tibial Sesamoid Position (TSP) as ≤ 3 at 6 weeks post-Lapiplasty® Procedure). Recurrence is defined by any two of the following three criteria being met at 24 months post-procedure: IMA of ≥12°, HVA ≥20° and TSP ≥4

    Time frame: 24 months

Secondary outcomes

  1. Radiographic Angular Measurements

    Change in radiographic angular/positional alignment before and after the Lapiplasty® Procedure \[Time Frame: pre-operatively, 6 weeks, 4 months, 6 months, 12 months, and 24 months, post-Lapiplasty® Procedure\].

    Time frame: pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure

  2. Number Of Patients With Radiographic Non-Union

    Union vs non-union -- Non-union defined as lucency at TMT joint, hardware failure and/or loss of correction, plus clinical pain at first TMT joint

    Time frame: 12 months post Lapiplasty® Procedure

  3. Clinical Complications Due to Lapiplasty® System Implants, the Procedure, the Post-op Weight-bearing Protocol or Health Conditions That Could Affect Other Outcome Measures - Measured by Adverse Events and Product Complaint Data

    Clinical complications due to Lapiplasty® System Implants, the procedure, the post-op weight-bearing protocol or health conditions that could affect other outcome measures - measured by Adverse Events and Product Complaint data

    Time frame: 24 months post Lapiplasty® Procedure

  4. Time to Start Weight-bearing in a Boot, in Days

    Time to start weight-bearing in a boot, in days

    Time frame: 0-3 weeks, post Lapiplasty® Procedure

  5. Time to Start Weight-bearing in a Shoe

    Time to start weight-bearing in a shoe

    Time frame: From time of procedure up to 6 weeks

  6. Time to Return to Full Unrestricted Activity, in Days

    Time to return to full unrestricted activity, in days

    Time frame: From time of procedure up to 4 months

  7. Change in Pain

    Change in pain assess via Visual Analog Scale (VAS), scale values 0-10, 0 indicates no pain and 10 indicates the worse possible pain. Assessed at 0-2 weeks, 2-3 weeks, 6 weeks, 4 months, 6 months, 12 months, and 24 months post Lapiplasty® Procedure, 6 weeks, 4 months, 6 months, 12 months, and 24 months reported.

    Time frame: 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure

  8. Change in Range of Motion

    1st MTP dorsiflexion and plantarflexion

    Time frame: 12 months, 24 months post Lapiplasty® Procedure

  9. Change in PROMIS - Quality of Life Score

    Each question has five response categories ranging in value from 1 to 5. The min and max response within each question is 1 and 5, respectively. The total raw score is calculated as the sum of the values of the responses to each question. The total raw score is then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Higher scores within the Physical Function and the Ability to Participate in Social Roles/Activities domains indicate better patient-reported health status. Lower scores within the Anxiety, Depression, Fatigue, Pain Interference, Sleep Disturbance, and Pain Intensity indicate better patient-reported health status.

    Time frame: 6 months, 12 months, 24 months post Lapiplasty® Procedure

  10. Change in Quality of Life - MOxFQ

    This instrument has 16 questions, each question has 5 response categories with scoring 0 to 4 where 0 represents the least problems and 4 represents greatest problems. The min and max response within each question is 0 and 4, respectively. The maximum possible raw score for the Walking/Standing domain is 28. The maximum possible raw score for the Pain domain is 20. The maximum possible raw score for the Social Interaction domain is 16. Scores for each domain are calculated separately, as the sum of each individual item (raw) score within that domain. In each case, this is then converted to a metric of 0 - 100 (higher score representing greater severity). Scores for the MOXFQ Index are initially calculated as the sum of all 16 individual item (raw) scores (maximum possible raw score 64). This is then converted to a metric of 0 - 100 (higher score representing greater severity).

    Time frame: 6 months, 12 months, 24 months post Lapiplasty® Procedure

  11. Change in Radiographic Foot Length

    Change in radiographic foot length compared to baseline visit.

    Time frame: 12 months post Lapiplasty® Procedure

  12. Change in Radiographic Foot Width

    Change in radiographic foot width (mm) compared to baseline visit

    Time frame: 12 months post Lapiplasty® Procedure

  13. Change in Swelling at Foot, Ankle & Mid-Calf (Circumference)

    Change in swelling as compared to 0-14 day visit.

    Time frame: 6 weeks and 4 months post Lapiplasty® Procedure

  14. Change in Scar Quality as Measured by Patient and Observer Scar Assessment Scale (POSAS)

    Change in scar quality in comparison to baseline visit. 1 equals the lowest score indicating normal skin to 10 the highest score indicating largest difference from normal skin of the 6 components on the scale. Total score can range from 6 to 60 by calculating the sum of all 6 components.

    Time frame: 4 months, 6 months, and 12 months post Lapiplasty® Procedure

  15. Change in Tibial Sesamoid Position (TSP)

    Change in radiographic angular/positional alignment before and after the Lapiplasty® Procedure \[Time Frame: pre-operatively, 6 weeks, 4 months, 6 months, 12 months, and 24 months, post-Lapiplasty® Procedure\]. Tibial Sesamoid Position (TSP) was graded from 1-7 and defined as the position of the medial sesamoid in relation to the longitudinal anatomic axis of the first metatarsal on AP radiographs based on the Hardy and Clapham classification. Lower TSP values (\<4) represent anatomic sesamoid reduction and triplanar correction. The importance of sesamoid reduction in maintenance of correction and patient outcomes has been published.

    Time frame: pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure

  16. Change in Osseous Foot Width (OFW)

    Change in radiographic angular/positional alignment before and after the Lapiplasty® Procedure \[Time Frame: pre-operatively, 6 weeks, 4 months, 6 months, 12 months, and 24 months, post-Lapiplasty® Procedure\].

    Time frame: pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure

06

Results

Posted Apr 20, 2026

Participant flow

Of 123 enrolled (signed informed consent) study subjects, 108 met inclusion and exclusion criteria and received surgical treatment. Of 108 who received surgical treatment, 3 were intraoperative screen failures and 105 continued in the study.

Participant flow — Overall Study
MilestoneSingle Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Started123
Number of patients who received study treatment105
Completed11
Not completed112

Outcome measures

PrimaryRadiographic Recurrence

Radiographic recurrence of hallux valgus deformity at 24 months for subjects with successful correction (defined as Intermetatarsal Angle (IMA) \<9.0°, Hallux Valgus Angle (HVA)\<15.0° and Tibial Sesamoid Position (TSP) as ≤ 3 at 6 weeks post-Lapiplasty® Procedure). Recurrence is defined by any two of the following three criteria being met at 24 months post-procedure: IMA of ≥12°, HVA ≥20° and TSP ≥4

Time frame:
24 months
Reported as:
Count of participants · Participants
Radiographic Recurrence
ParticipantsSingle Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Radiographic Recurrence0
SecondaryRadiographic Angular Measurements

Change in radiographic angular/positional alignment before and after the Lapiplasty® Procedure \[Time Frame: pre-operatively, 6 weeks, 4 months, 6 months, 12 months, and 24 months, post-Lapiplasty® Procedure\].

Time frame:
pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure
Reported as:
Mean · Degree
Radiographic Angular Measurements
DegreeSingle Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Baseline HVA26.6 (25.3 to 27.8)
Baseline IMA14.1 (13.5 to 14.6)
Baseline Sagittal Plane0.3 (-0.1 to 0.8)
HVA Change from Baseline at Week 6-20.3 (-21.7 to -18.8)
IMA Change from Baseline at Week 6-10.4 (-11.0 to -9.8)
Sagittal Plane change from Baseline at Week 61.4 (0.8 to 2.0)
HVA Change from Baseline at Month 4-20.1 (-21.4 to -18.7)
IMA Change from Baseline at Month 4-9.9 (-10.5 to -9.3)
Sagittal Plane Change from Baseline at Month 41.0 (0.4 to 1.6)
HVA Change from Baseline at Month 6-20.2 (-21.7 to -18.8)
IMA Change from Baseline at Month 6-9.5 (-10.1 to -8.8)
Sagittal Plane Change from Baseline at Month 61.0 (0.4 to 1.5)
HVA Change from Baseline at Month 12-19.3 (-20.9 to -17.6)
IMA Change from Baseline at Month 12-9.4 (-10.1 to -8.8)
Sagittal Plane Change from Baseline at Month 120.9 (0.3 to 1.6)
HVA Change from Baseline at Month 24-18.6 (-23.0 to -14.3)
IMA Change from Baseline at Month 24-10.0 (-11.4 to -8.5)
Sagittal Plane Change from Baseline at Month 241.4 (-0.9 to 3.7)
SecondaryNumber Of Patients With Radiographic Non-Union

Union vs non-union -- Non-union defined as lucency at TMT joint, hardware failure and/or loss of correction, plus clinical pain at first TMT joint

Time frame:
12 months post Lapiplasty® Procedure
Reported as:
Count of participants · Participants
Number Of Patients With Radiographic Non-Union
ParticipantsSingle Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Number Of Patients With Radiographic Non-Union0
SecondaryClinical Complications Due to Lapiplasty® System Implants, the Procedure, the Post-op Weight-bearing Protocol or Health Conditions That Could Affect Other Outcome Measures - Measured by Adverse Events and Product Complaint Data

Clinical complications due to Lapiplasty® System Implants, the procedure, the post-op weight-bearing protocol or health conditions that could affect other outcome measures - measured by Adverse Events and Product Complaint data

Time frame:
24 months post Lapiplasty® Procedure
Reported as:
Count of participants · Participants
Clinical Complications Due to Lapiplasty® System Implants, the Procedure, the Post-op Weight-bearing Protocol or Health Conditions That Could Affect Other Outcome Measures - Measured by Adverse Events and Product Complaint Data
ParticipantsSingle Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Hardware removal due to pain1
Hardware failure (hardware not removed)1
Pain5
Infection2
Allergic reaction to surgical glue1
Malunion1
Skin abrasion1
Cuneiform fracture1
Stiffness1
SecondaryTime to Start Weight-bearing in a Boot, in Days

Time to start weight-bearing in a boot, in days

Time frame:
0-3 weeks, post Lapiplasty® Procedure
Reported as:
Mean · Days
Time to Start Weight-bearing in a Boot, in Days
DaysSingle Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Time to Start Weight-bearing in a Boot, in Days7.9 (6.7 to 9.1)
SecondaryTime to Start Weight-bearing in a Shoe

Time to start weight-bearing in a shoe

Time frame:
From time of procedure up to 6 weeks
Reported as:
Mean · Days
Time to Start Weight-bearing in a Shoe
DaysSingle Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Time to Start Weight-bearing in a Shoe43.0 (41.2 to 44.8)
SecondaryTime to Return to Full Unrestricted Activity, in Days

Time to return to full unrestricted activity, in days

Time frame:
From time of procedure up to 4 months
Reported as:
Mean · Days
Time to Return to Full Unrestricted Activity, in Days
DaysSingle Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Time to Return to Full Unrestricted Activity, in Days115.0 (104.5 to 125.5)
SecondaryChange in Pain

Change in pain assess via Visual Analog Scale (VAS), scale values 0-10, 0 indicates no pain and 10 indicates the worse possible pain. Assessed at 0-2 weeks, 2-3 weeks, 6 weeks, 4 months, 6 months, 12 months, and 24 months post Lapiplasty® Procedure, 6 weeks, 4 months, 6 months, 12 months, and 24 months reported.

Time frame:
6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure
Reported as:
Mean · score on a scale
Change in Pain
score on a scaleSingle Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Baseline3.5 (3.1 to 3.9)
Change from Baseline at 6 Weeks-1.8 (-2.3 to -1.4)
Change from Baseline at 4 Months-2.1 (-2.5 to -1.6)
Change from Baseline at 6 Months-2.3 (-2.7 to -1.8)
Change from Baseline at 12 Months-2.6 (-3.2 to -2.1)
Change from Baseline at 24 Months-1.9 (-3.2 to -0.6)
SecondaryChange in Range of Motion

1st MTP dorsiflexion and plantarflexion

Time frame:
12 months, 24 months post Lapiplasty® Procedure
Reported as:
Mean · degrees
Change in Range of Motion
degreesSingle Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Baseline - Range of Motion -Dorsiflexion61.8 (59.2 to 64.4)
Change from Baseline - Range of Motion 12 mo Dorsiflexion-4.5 (-8.0 to -1.1)
Change from Baseline - Range of Motion 24 mo Dorsiflexion0.3 (-15.5 to 16.1)
Baseline - Range of Motion - Plantarflexion26.4 (23.8 to 29.1)
Change from Baseline - Range of Motion 12 mo Plantarflexion0.2 (-3.2 to 3.6)
Change from Baseline - Range of Motion 24 mo Plantarflexion-7.0 (-15.8 to 1.8)
SecondaryChange in PROMIS - Quality of Life Score

Each question has five response categories ranging in value from 1 to 5. The min and max response within each question is 1 and 5, respectively. The total raw score is calculated as the sum of the values of the responses to each question. The total raw score is then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Higher scores within the Physical Function and the Ability to Participate in Social Roles/Activities domains indicate better patient-reported health status. Lower scores within the Anxiety, Depression, Fatigue, Pain Interference, Sleep Disturbance, and Pain Intensity indicate better patient-reported health status.

Time frame:
6 months, 12 months, 24 months post Lapiplasty® Procedure
Reported as:
Mean · score on a scale
Change in PROMIS - Quality of Life Score
score on a scaleSingle Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Baseline PROMIS-25 -Pediatric - Anxiety55.8 (42.8 to 68.8)
Change from Baseline 6 Month PROMIS-25 -Pediatric - Anxiety-11.9 (-25.9 to 2.1)
Change from Baseline 12 Months PROMIS-25 - Pediatric - Anxiety-15.7 (-36.2 to 4.9)
Baseline PROMIS-25 -Pediatric - Depression49.6 (40.0 to 59.1)
Change from Baseline 6 Month PROMIS-25 -Pediatric - Depression-7.2 (-10.9 to -3.4)
Change from Baseline 12 Months PROMIS-25 - Pediatric - Depression-1.7 (-10.2 to 6.9)
Baseline PROMIS-25 -Pediatric - Fatigue49.7 (37.0 to 62.4)
Change from Baseline 6 Month PROMIS-25 -Pediatric - Fatigue-11.9 (-23.9 to 0.1)
Change from Baseline 12 Months PROMIS-25 - Pediatric - Fatigue-10.9 (-25.9 to 4.1)
Baseline PROMIS-25 -Pediatric - Pain Intensity2.3 (1.2 to 3.4)
Change from Baseline 6 Month PROMIS-25 -Pediatric - Pain Intensity-0.5 (-3.7 to 2.7)
Change from Baseline 12 Month PROMIS-25 -Pediatric - Pain Intensity-1.0 (-3.5 to 1.5)
Baseline PROMIS-25 -Pediatric - Pain Interference52.6 (45.8 to 59.4)
Change from Baseline 6 Month PROMIS-25 -Pediatric - Pain Interference-7.1 (-21.6 to 7.5)
Change from Baseline 12 Month PROMIS-25 -Pediatric - Pain Inteference-9.9 (-20.6 to 0.7)
Baseline PROMIS-25 -Pediatric - Peer Relationships53.3 (46.0 to 60.6)
Change from Baseline 6 Month PROMIS-25 -Pediatric - Peer Relationships3.0 (-2.5 to 8.5)
Change from Baseline 12 Month PROMIS-25 -Pediatric - Peer Relationships2.4 (-6.0 to 10.9)
Baseline PROMIS-25 Pediatric - Physical Function46.3 (38.6 to 53.9)
Change from Baseline 6 Month PROMIS-25 -Pediatric - Physical Function5.2 (-5.1 to 15.4)
Change from Baseline 12 Month PROMIS-25 -Pediatric - Physical Function7.5 (-3.6 to 18.7)
Baseline PROMIS-29- Ability to Participate in Social Roles/Activities54.1 (52.3 to 56.0)
Change from Baseline 6 Month - PROMIS-29-Adult - Ability to Participate in Social Roles/Activities4.7 (3.0 to 6.4)
Change from Baseline 12 Month - PROMIS-29-Adult - Ability to Participate in Social Roles/Activities7.2 (5.0 to 9.3)
Change from Baseline 24 Month - PROMIS-29-Adult - Ability to Participate in Social Roles/Activities7.1 (2.8 to 11.3)
Baseline PROMIS-29- Adult - Anxiety48.3 (46.3 to 50.2)
Change from Baseline 6 Month PROMIS-29- Adult - Anxiety-3.4 (-5.2 to -1.6)
Change from Baseline 12 Month PROMIS-29- Adult - Anxiety-4.7 (-6.7 to -2.6)
Change from Baseline 24 Month PROMIS-29- Adult - Anxiety-7.8 (-15.6 to -0.1)
Baseline PROMIS-29- Adult - Depression44.9 (43.3 to 46.4)
Change from Baseline 6 Month PROMIS-29- Adult - Depression-1.3 (-2.5 to -0.1)
Change from Baseline 12 Month PROMIS-29- Adult - Depression-1.5 (-2.9 to -0.2)
Change from Baseline 24 Month PROMIS-29- Adult - Depression-4.8 (-11.8 to 2.2)
Baseline PROMIS-29- Adult - Fatigue45.8 (43.7 to 47.8)
Change from Baseline 6 Month PROMIS-29- Adult - Fatigue-3.5 (-5.4 to -1.6)
Change from Baseline 12 Month PROMIS-29- Adult - Fatigue-4.6 (-6.7 to -2.5)
Change from Baseline 24 Month PROMIS-29- Adult - Fatigue-5.8 (-13.0 to 1.4)
Baseline PROMIS-29- Adult - Pain Intensity3.9 (3.5 to 4.3)
Change from Baseline 6 Month PROMIS-29- Adult - Pain Intensity-2.5 (-3.0 to -2.0)
Change from Baseline 12 Month PROMIS-29- Adult - Pain Intensity-3.1 (-3.7 to -2.5)
Change from Baseline 24 Month PROMIS-29- Adult - Pain Intensity-2.9 (-4.3 to -1.5)
Baseline PROMIS-29- Adult - Pain Interference54.1 (52.4 to 55.8)
Change from Baseline 6 Month PROMIS-29- Adult - Pain Interference-8.2 (-10 to -6.4)
Change from Baseline 12 Month PROMIS-29- Adult - Pain Interference-10.4 (-12.4 to -8.3)
Change from Baseline 24 Month PROMIS-29- Adult - Pain Interference-9.3 (-13.1 to -5.5)
Baseline PROMIS-29- Adult - Physical Function45.9 (44.2 to 47.5)
Change from Baseline 6 Month PROMIS-29- Adult - Physical Function6.8 (4.9 to 8.7)
Change from Baseline 12 Month PROMIS-29- Adult - Physical Function9.5 (7.5 to 11.4)
Change from Baseline 24 Month PROMIS-29- Adult - Physical Function8.5 (3.4 to 13.6)
Baseline PROMIS-29- Adult - - Sleep Disturbance49.1 (47.6 to 50.6)
Change from Baseline 6 Month PROMIS-29- Adult - Sleep Disturbance-4.0 (-5.6 to -2.3)
Change from Baseline 12 Month PROMIS-29- Adult - Sleep Disturbance-4.8 (-6.5 to -3.1)
Change from Baseline 24 Month PROMIS-29- Adult - Sleep Disturbance-4.2 (-12.4 to 4.1)
SecondaryChange in Quality of Life - MOxFQ

This instrument has 16 questions, each question has 5 response categories with scoring 0 to 4 where 0 represents the least problems and 4 represents greatest problems. The min and max response within each question is 0 and 4, respectively. The maximum possible raw score for the Walking/Standing domain is 28. The maximum possible raw score for the Pain domain is 20. The maximum possible raw score for the Social Interaction domain is 16. Scores for each domain are calculated separately, as the sum of each individual item (raw) score within that domain. In each case, this is then converted to a metric of 0 - 100 (higher score representing greater severity). Scores for the MOXFQ Index are initially calculated as the sum of all 16 individual item (raw) scores (maximum possible raw score 64). This is then converted to a metric of 0 - 100 (higher score representing greater severity).

Time frame:
6 months, 12 months, 24 months post Lapiplasty® Procedure
Reported as:
Mean · score on a scale
Change in Quality of Life - MOxFQ
score on a scaleSingle Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Baseline - MOxFQ- Social Interaction42.7 (38.7 to 46.8)
Change from Baseline - 6 mo - MOxFQ - Social Interaction-27.4 (-32.0 to -22.8)
Change from Baseline - 12 mo - MOxFQ - Social Interaction-33.8 (-38.6 to -28.9)
Change from Baseline - 24 mo - MOxFQ - Social Interaction-28.4 (-42.9 to -13.9)
Baseline - MOxFQ- Walking/Standing41.2 (36.7 to 45.8)
Change from Baseline - 6 mo - MOxFQ - Walking/Standing-22.3 (-27.7 to -16.9)
Change from Baseline - 12 mo - MOxFQ - Walking/Standing-32.0 (-37.9 to -26.0)
Change from Baseline - 24 mo - MOxFQ - Walking/Standing-26.6 (-39.7 to -13.5)
Baseline - MOxFQ - Pain50.2 (46.6 to 53.9)
Change from Baseline - 6 mo - MOxFQ - Pain-26.8 (-31.9 to -21.7)
Change from Baseline - 12 mo - MOxFQ - Pain-36.7 (-42.4 to -31.1)
Change from Baseline - 24 mo - MOxFQ - Pain-38.2 (-51.4 to -25)
Baseline - MOxFQ - Index Score44.4 (40.8 to 48.1)
Change from Baseline - 6 mo - MOxFQ - Index Score-25.0 (-29.5 to -20.4)
Change from Baseline - 12 mo - MOxFQ - Index Score-33.9 (-38.8 to -29.0)
Change from Baseline - 24 mo - MOxFQ - Index Score-30.7 (-41.6 to -19.7)
SecondaryChange in Radiographic Foot Length

Change in radiographic foot length compared to baseline visit.

Time frame:
12 months post Lapiplasty® Procedure
Reported as:
Mean · mm
Change in Radiographic Foot Length
mmSingle Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Baseline Sagittal Length84.7 (83.0 to 86.4)
Change from Baseline - Sagittal Length - 12 mo-1.8 (-2.5 to -1.2)
SecondaryChange in Radiographic Foot Width

Change in radiographic foot width (mm) compared to baseline visit

Time frame:
12 months post Lapiplasty® Procedure
Reported as:
Mean · mm
Change in Radiographic Foot Width
mmSingle Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Baseline Osseous Foot Width91.0 (89.1 to 93.0)
Change from Baseline - Osseous Foot Width - 12 mo-7.0 (-7.8 to -6.2)
SecondaryChange in Swelling at Foot, Ankle & Mid-Calf (Circumference)

Change in swelling as compared to 0-14 day visit.

Time frame:
6 weeks and 4 months post Lapiplasty® Procedure
Reported as:
Mean · cm
Change in Swelling at Foot, Ankle & Mid-Calf (Circumference)
cmSingle Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Baseline Mid-Foot Circumference20.2 (19.6 to 20.8)
Change from Baseline - 6 week Mid-Foot Circumference0.7 (0.4 to 1.0)
Change from Baseline - 4 mo - Mid-Foot Circumference0.3 (0.0 to 0.6)
Baseline Fore-Foot Circumference20.7 (20.1 to 21.3)
Change from Baseline - 6 week Fore-Foot Circumference0.1 (-0.1 to 0.4)
Change from Baseline - 4 mo Fore-Foot Circumference-0.5 (-0.7 to -0.2)
Baseline Ankle Circumference20.7 (19.9 to 21.5)
Change from Baseline - 6 week Ankle Circumference0.2 (-0.2 to 0.5)
Change from Baseline - 4 mo Ankle Circumference0.1 (-0.3 to 0.5)
Baseline Calf Circumference33.4 (32.5 to 34.3)
Change from Baseline - 6 week Calf Circumference-1.9 (-2.5 to -1.3)
Change from Baseline - 4 mo Calf Circumference-1.0 (-1.6 to -0.5)
SecondaryChange in Scar Quality as Measured by Patient and Observer Scar Assessment Scale (POSAS)

Change in scar quality in comparison to baseline visit. 1 equals the lowest score indicating normal skin to 10 the highest score indicating largest difference from normal skin of the 6 components on the scale. Total score can range from 6 to 60 by calculating the sum of all 6 components.

Time frame:
4 months, 6 months, and 12 months post Lapiplasty® Procedure
Reported as:
Mean · score on a scale
Change in Scar Quality as Measured by Patient and Observer Scar Assessment Scale (POSAS)
score on a scaleSingle Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
POSAS Observer - 4 mo14.6 (13.4 to 15.9)
POSAS Observer - 6 mo12.1 (11.2 to 13.1)
POSAS Observer - 12 mo10.8 (9.8 to 11.8)
POSAS Patient - 4 mo22.7 (20.4 to 24.9)
POSAS Patient - 6 mo18.2 (16.0 to 20.4)
POSAS Patient - 12 mo13.4 (11.6 to 15.2)
SecondaryChange in Tibial Sesamoid Position (TSP)

Change in radiographic angular/positional alignment before and after the Lapiplasty® Procedure \[Time Frame: pre-operatively, 6 weeks, 4 months, 6 months, 12 months, and 24 months, post-Lapiplasty® Procedure\]. Tibial Sesamoid Position (TSP) was graded from 1-7 and defined as the position of the medial sesamoid in relation to the longitudinal anatomic axis of the first metatarsal on AP radiographs based on the Hardy and Clapham classification. Lower TSP values (\<4) represent anatomic sesamoid reduction and triplanar correction. The importance of sesamoid reduction in maintenance of correction and patient outcomes has been published.

Time frame:
pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure
Reported as:
Mean · score on a scale
Change in Tibial Sesamoid Position (TSP)
score on a scaleSingle Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Baseline TSP5.0 (4.8 to 5.3)
TSP Change from Baseline at Week 61.7 (1.5 to 1.9)
TSP Change from Baseline at Month 42.1 (1.9 to 2.4)
TSP Change from Baseline at Month 62.3 (2.1 to 2.6)
TSP Change from Baseline at Month 122.7 (2.4 to 3.0)
TSP Change from Baseline at Month 241.9 (1.4 to 2.5)
SecondaryChange in Osseous Foot Width (OFW)

Change in radiographic angular/positional alignment before and after the Lapiplasty® Procedure \[Time Frame: pre-operatively, 6 weeks, 4 months, 6 months, 12 months, and 24 months, post-Lapiplasty® Procedure\].

Time frame:
pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure
Reported as:
Mean · mm
Change in Osseous Foot Width (OFW)
mmSingle Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Baseline Osseous Foot Width91.0 (89.1 to 93.0)
Baseline Sagittal 1st Ray Length84.7 (83.0 to 86.4)
Baseline 1-2 Metatarsal Length-3.0 (-3.5 to -2.4)
Osseous Foot Width Change from Baseline at Month 6-7.4 (-8.0 to -6.8)
Sagittal 1st Ray Length Change from Baseline at Month 6-2.0 (-2.5 to -1.5)
1-2 Metatarsal Length Change from Baseline at Month 6-2.6 (-3.0 to -2.2)
Osseous Foot Width Change from Baseline at Month 12-7.0 (-7.8 to -6.2)
Sagittal 1st Ray Length Change from Baseline at Month 12-1.8 (-2.5 to -1.2)
1-2 Metatarsal Length Change from Baseline at Month 12-2.4 (-2.8 to -2.1)
Osseous Foot Width Change from Baseline at Month 24-8.6 (-12.4 to -4.7)
Sagittal 1st Ray Length Change from Baseline at Month 24-3.9 (-6.5 to -1.3)
1-2 Metatarsal Length Change from Baseline at Month 24-2.6 (-3.7 to -1.5)

Adverse events

Collected over 24 months. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision0/105 (0%)1/105 (1%)11/105 (10.5%)
Most frequent serious events
Most frequent serious events
EventSingle Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
PainMusculoskeletal and connective tissue disorders1/105
Most frequent other events
Most frequent other events
EventSingle Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
PainMusculoskeletal and connective tissue disorders5/105
InfectionMusculoskeletal and connective tissue disorders2/105
Allergic reaction to surgical glueMusculoskeletal and connective tissue disorders1/105
MalunionMusculoskeletal and connective tissue disorders1/105
Skin abrasion, superficial abscess due to activity along distal incisionMusculoskeletal and connective tissue disorders1/105
StiffnessMusculoskeletal and connective tissue disorders1/105
Cuneiform fractureMusculoskeletal and connective tissue disorders1/105

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
<=18 years7
Between 18 and 65 years98
>=65 years0
Age, Continuous
Age, Continuous(years)Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Mean41.0 ± 12.4
Sex: Female, Male
Sex: Female, Male(Participants)Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Female98
Male7
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Hispanic or Latino22
Not Hispanic or Latino83
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
American Indian or Alaska Native1
Asian9
Native Hawaiian or Other Pacific Islander0
Black or African American10
White80
More than one race1
Unknown or Not Reported4
Region of Enrollment
Region of Enrollment(participants)Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
United States105
BMI
BMI(kg/m^2)Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Mean25.2 ± 4.9
Operative Foot
Operative Foot(Participants)Single Arm Tri-Planar Tarsometatarsal Joint Arthrodesis With Lapiplasty® Through a Mini-Incision
Left Foot54
Right Foot51

1 further baseline measures are reported on the registry.

07

Study locations

10 sites
  • DOC - Decatur Orthopaedic Clinic
    Decatur, Alabama 35601, United States
  • DOC - Decatur Orthopaedic Clinic
    Hartselle, Alabama 35640, United States
  • Phoenix Foot and Ankle Institute
    Scottsdale, Arizona 85251, United States
  • Orlando Foot and Ankle Clinic - Waterford Lakes Office
    Orlando, Florida 32825, United States
  • JCMG - Podiatry
    Jefferson City, Missouri 65109, United States
  • Desert Orthopaedic Center
    Las Vegas, Nevada 89121, United States
  • University of Pennsylvania / Penn Medicine
    Philadelphia, Pennsylvania 19106, United States
  • Stonebriar Foot and Ankle
    Frisco, Texas 75034, United States
  • Foot & Ankle Associates of North Texas - Keller
    Keller, Texas 76248, United States
  • Sports Medicine Associates of San Antonio
    San Antonio, Texas 78240, United States
08

References and documents

Study documents

  • Study protocol · Apr 4, 2023
  • Statistical analysis plan · Apr 4, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT05082012
Lead sponsor
Treace Medical Concepts, Inc.
Responsible party
Sponsor
First posted
Oct 18, 2021
Start date
Sep 17, 2021
Primary completion
May 9, 2024
Completion
May 9, 2024
Results posted
Apr 20, 2026
Last update
Apr 20, 2026

Study contacts

Jody McAleer, DPM, FACFAS
principal investigator · JCMG - Podiatry

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hallux Valgus→

Other studies from this sponsor

Treace Medical Concepts, Inc.

Start the discussion