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Status unknownNCT04614675Updated Nov 4, 2020

Transarticular Lateral Release Versus Percutaneous Lateral Release for Hallux Valgus

An interventional study of Distal soft tissue procedure with TALR and Distal soft tissue procedure with PCLR in Hallux Valgus, sponsored by Taipei Veterans General Hospital, Taiwan. Status unknown. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-11-04.

Sponsored by Taipei Veterans General Hospital, Taiwan · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

background Hallux valgus (HV) is a common forefoot disorder in need of surgical intervention after failed conservative treatment. Surgical treatment of HV generally includes different kinds of osteotomy in combination with different distal soft tissue procedures (DSTP). Commonly used DSTP are open first-web lateral release, transarticular lateral release (TALR), and percutaneous lateral release (PCLR). In some studies, TALR showed similar surgical outcomes with open first-web space lateral release. Besides, PCLR has been described with satisfactory outcomes. TALR and PCLR are gaining popularity due to their less invasive approach and potential in combination with a distal metatarsal Chevron osteotomy (DMCO). Currently, there is no study comparing the surgical results between TALR and PCLR for surgical reconstruction of HV.

Aim The aim of this prospective randomized trial is to compare the surgical outcomes of TALR versus PCLR, both in combination of DMCO, for the treatment of HV. Our hypothesis is that TALR would achieve a better surgical outcomes than PCLR.

Read the detailed description

This study will be conducted from January, 2021 to December, 2024. A total of 140 participants are included with 70 participants in each group. Participants are allocated to TALR or PCLR group before index surgery according to a computer-generated randomization list.

For all patients, after regional nerve block and adequate sedation, intraoperative stress test is performed for flexibility of first metatarsophalangeal joint (MTPJ).6 The test is confirmed with dorsoplantar fluoroscopy. Only the cases with negative results (passive correction is not possible) are included. Then, a medial incision of 2.5-cm is made at distal metatarsal head and a reverse L-shaped medial capsulotomy is made followed by TALR or PCLR.

After TALR or PCLR, medial bunionectomy is performed. DMCO is made with the apex at distal metatarsal neck and angle of 60 to 90 degrees. The metatarsal head is laterally moved and fixed with one or 2 oblique headless compression screws.

Postoperative followup The patients are followed up at two weeks for removal of stitches, then 1-month, 2-month, 3-month, 6-months, 1-year, and annually after 1 year for radiographic , functional assessments, and evaluation of complications.

Power analysis for patient number With the assumption of mean HVA are 10 degrees for TALR group and 15 degrees for PCLR group at final followup, and a standard deviation of 8 degrees for both groups, the calculated effect size d is 0.625. In order to achieve the α error probability of 0.05 and power of 0.95, 68 participants in each group are necessary with a total of 136 participants in this study.

Statistical analysis In the comparisons between TALR and PCLR groups, the independent two samples t-test and the Mann-Whitney test are performed for normal and non-normal distributed data respectively, and the Fisher's exact test is performed for categorical data. P-values less than 0.05 is considered to be statistical significant. The statistical analyses are performed by using SPSS 25.0 statistics software (SPSS Inc, Chicago, USA).

Clinical relevance

  1. Compare the differences of surgical outcomes between TALR and PCLR. These results could offer valuable information for foot and ankle surgeon.
  2. If PCLR is not adequate to achieve satisfactory outcomes, the minimally invasive surgery using PCLR for HV is not recommended.
02

Conditions studied

  • Hallux Valgus

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Keywords

  • Hallux valgus
  • Distal soft tissue procedure
  • Transarticular lateral release (TALR)
  • Percutaneous lateral release (PCLR)
  • Minimally invasive surgery
03

In context

Hallux Valgus

157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.

This study's planned enrollment of 140 is above the median of 58 across 119 interventional studies indexed under Hallux Valgus.

Browse Hallux Valgus studies →

Lead sponsor

Taipei Veterans General Hospital, Taiwan is the lead sponsor of 338 studies on the registry; 74 are open to participants now.

Browse Taipei Veterans General Hospital, Taiwan studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age equal or greater than 20 years
  • Hallux valgus angle (HVA) equal or greater than 20 degrees
  • Persistent symptoms after failed conservative treatment
  • Receiving DMCO for HV

Exclusion criteria

Exclusion Criteria:

  • Underlying rheumatoid or other inflammatory arthritis
  • Hallux rigidus
  • Recurrent hallux valgus after previous surgery
  • First tarsometatarsal hypermobility
  • A positive intraoperative stress test for lateral soft tissue release
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • Active comparator
    Transarticular lateral release (TALR)

    TALR The first toe is pulled distally for access into the lateral aspect of first MTPJ. A No.15 beaver blade is advanced from the medial incision laterally to divide the lateral capsule vertically and adductor hallucis tendon. Same intraoperative stress test is performed and recorded under fluoroscope to confirm correction.

    Procedure: Distal soft tissue procedure with TALR

  • Active comparator
    Percutaneous lateral release (PCLR)

    PCLR A 0.5 cm stab wound is made at lateral aspect of first MTPJ. A No. 15 beaver blade is advanced into the lateral side of MTPJ with a quarter of the blade inside the joint and verified with fluoroscope. The blade is turned laterally to face the adductor hallucis tendon. The adductor tendon is divided with lateral movement of the blade and varus manipulation of proximal phalanx. A click is heard as adequate release of adductor hallucis tendon. Same intraoperative stress test is performed and recorded under fluoroscope to confirm correction.

    Procedure: Distal soft tissue procedure with PCLR

Interventions

  • ProcedureDistal soft tissue procedure with TALR

    TALR group: Transarticular lateral release as the distal soft tissue procedure

  • ProcedureDistal soft tissue procedure with PCLR

    PCLR: Percutaneous soft tissue procedures as the distal soft tissue procedure

06

What researchers measure

Primary outcomes

  1. hallux valgus angle (HVA)(degrees)

    weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal

    Time frame: postoperative 1-month

  2. hallux valgus angle (HVA)(degrees)

    weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal

    Time frame: postoperative 2-month

  3. hallux valgus angle (HVA)(degrees)

    weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal

    Time frame: postoperative 3-month

  4. hallux valgus angle (HVA)(degrees)

    weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal

    Time frame: postoperative 6-month

  5. hallux valgus angle (HVA)(degrees)

    weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal

    Time frame: postoperative 12-month

  6. hallux valgus angle (HVA)(degrees)

    weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal

    Time frame: postoperative 24-month

  7. hallux valgus angle (HVA)(degrees)

    weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal

    Time frame: postoperative 36-month

  8. intermetatarsal angle (IMA) 1-2 (degrees)

    weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal

    Time frame: postoperative 1-month

  9. intermetatarsal angle (IMA) 1-2 (degrees)

    weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal

    Time frame: postoperative 2-month

  10. intermetatarsal angle (IMA) 1-2 (degrees)

    weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal

    Time frame: postoperative 3-month

  11. intermetatarsal angle (IMA) 1-2 (degrees)

    weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal

    Time frame: postoperative 6-month

  12. intermetatarsal angle (IMA) 1-2 (degrees)

    weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal

    Time frame: postoperative 12-month

  13. intermetatarsal angle (IMA) 1-2 (degrees)

    weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal

    Time frame: postoperative 24-month

  14. intermetatarsal angle (IMA) 1-2 (degrees)

    weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal

    Time frame: postoperative 36-month

  15. sesamoid position

    weightbearing dorsoplantar radiograph, the location of the medial sesamoid with progressive lateral subluxation from grade one to seven according to the classification system of Hardy and Clapham

    Time frame: postoperative 1-month

  16. sesamoid position

    weightbearing dorsoplantar radiograph, the location of the medial sesamoid with progressive lateral subluxation from grade one to seven according to the classification system of Hardy and Clapham

    Time frame: postoperative 2-month

  17. sesamoid position

    weightbearing dorsoplantar radiograph, the location of the medial sesamoid with progressive lateral subluxation from grade one to seven according to the classification system of Hardy and Clapham

    Time frame: postoperative 3-month

  18. sesamoid position

    weightbearing dorsoplantar radiograph, the location of the medial sesamoid with progressive lateral subluxation from grade one to seven according to the classification system of Hardy and Clapham

    Time frame: postoperative 6-month

  19. sesamoid position

    weightbearing dorsoplantar radiograph, the location of the medial sesamoid with progressive lateral subluxation from grade one to seven according to the classification system of Hardy and Clapham

    Time frame: postoperative 12-month

  20. sesamoid position

    weightbearing dorsoplantar radiograph, the location of the medial sesamoid with progressive lateral subluxation from grade one to seven according to the classification system of Hardy and Clapham

    Time frame: postoperative 24-month

  21. sesamoid position

    weightbearing dorsoplantar radiograph, the location of the medial sesamoid with progressive lateral subluxation from grade one to seven according to the classification system of Hardy and Clapham

    Time frame: postoperative 36-month

  22. visual analogue scale (VAS) for pain

    pain score, (0-10, the lower the better)

    Time frame: postoperative 3-months

  23. visual analogue scale (VAS) for pain

    pain score, (0-10, the lower the better)

    Time frame: postoperative 6-months

  24. visual analogue scale (VAS) for pain

    pain score, (0-10, the lower the better)

    Time frame: postoperative 12-months

  25. visual analogue scale (VAS) for pain

    pain score, (0-10, the lower the better)

    Time frame: postoperative 24-months

  26. visual analogue scale (VAS) for pain

    pain score, (0-10, the lower the better)

    Time frame: postoperative 36-months

  27. hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)

    functional score, 0-100, the higher the better

    Time frame: postoperative 3-months

  28. hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)

    functional score, 0-100, the higher the better

    Time frame: postoperative 6-months

  29. hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)

    functional score, 0-100, the higher the better

    Time frame: postoperative 12-months

  30. hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)

    functional score, 0-100, the higher the better

    Time frame: postoperative 24-months

  31. hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)

    functional score, 0-100, the higher the better

    Time frame: postoperative 36-months

Secondary outcomes

  1. rate of osteonecrosis of first metatarsal head

    postoperative complications

    Time frame: 12-month

  2. rate of osteonecrosis of first metatarsal head

    postoperative complications

    Time frame: 24-month

  3. rate of osteonecrosis of first metatarsal head

    postoperative complications

    Time frame: 36-month

  4. rate of numbness of hallux

    postoperative complication

    Time frame: 12-month

  5. rate of numbness of hallux

    postoperative complication

    Time frame: 24-month

  6. rate of numbness of hallux

    postoperative complication

    Time frame: 36-month

  7. rate of infection

    postoperative complication

    Time frame: 12-month

  8. rate of infection

    postoperative complication

    Time frame: 24-month

  9. rate of infection

    postoperative complication

    Time frame: 36-month

  10. rate of first MTPJ arthritis

    postoperative complication

    Time frame: 12-month

  11. rate of first MTPJ arthritis

    postoperative complication

    Time frame: 24-month

  12. rate of first MTPJ arthritis

    postoperative complication

    Time frame: 36-month

  13. rate of recurrent hallux valgus

    postoperative complication, hallux valgus angle equal or greater than 20 degrees

    Time frame: 12-month

  14. rate of recurrent hallux valgus

    postoperative complication, hallux valgus angle equal or greater than 20 degrees

    Time frame: 24-month

  15. rate of recurrent hallux valgus

    postoperative complication, hallux valgus angle equal or greater than 20 degrees

    Time frame: 36-month

  16. rate of hallux varus

    postoperative complication

    Time frame: 12-month

  17. rate of hallux varus

    postoperative complication

    Time frame: 24-month

  18. rate of hallux varus

    postoperative complication

    Time frame: 36-month

  19. rate of reoperations

    postoperative complication

    Time frame: 12-month

  20. rate of reoperations

    postoperative complication

    Time frame: 24-month

  21. rate of reoperations

    postoperative complication

    Time frame: 36-month

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Wagner E, Ortiz C, Figueroa F, Vela O, Wagner P, Gould JS. Role of a Limited Transarticular Release in Severe Hallux Valgus Correction. Foot Ankle Int. 2015 Nov;36(11):1322-9. doi: 10.1177/1071100715593082. Epub 2015 Jul 7. PubMed 26152873 ↗
  • Lee KB, Cho NY, Park HW, Seon JK, Lee SH. A comparison of proximal and distal Chevron osteotomy, both with lateral soft-tissue release, for moderate to severe hallux valgus in patients undergoing simultaneous bilateral correction: a prospective randomised controlled trial. Bone Joint J. 2015 Feb;97-B(2):202-7. doi: 10.1302/0301-620X.97B2.34449. PubMed 25628283 ↗
  • Park CH, Jang JH, Lee SH, Lee WC. A comparison of proximal and distal chevron osteotomy for the correction of moderate hallux valgus deformity. Bone Joint J. 2013 May;95-B(5):649-56. doi: 10.1302/0301-620X.95B5.30181. PubMed 23632675 ↗
  • Park YB, Lee KB, Kim SK, Seon JK, Lee JY. Comparison of distal soft-tissue procedures combined with a distal chevron osteotomy for moderate to severe hallux valgus: first web-space versus transarticular approach. J Bone Joint Surg Am. 2013 Nov 6;95(21):e158. doi: 10.2106/JBJS.L.01017. PubMed 24196470 ↗
  • Ahn JY, Lee HS, Chun H, Kim JS, Seo DK, Choi YR, Kim SW. Comparison of open lateral release and transarticular lateral release in distal chevron metatarsal osteotomy for hallux valgus correction. Int Orthop. 2013 Sep;37(9):1781-7. doi: 10.1007/s00264-013-2023-1. Epub 2013 Aug 6. PubMed 23917851 ↗
  • de Las Heras-Romero J, Lledo-Alvarez AM, Andres-Grau J, Picazo-Marin F, Moreno-Sanchez JF, Hernandez-Torralba M. A new minimally extended distal Chevron osteotomy (MEDCO) with percutaneous soft tissue release (PSTR) for treatment of moderate hallux valgus. Foot (Edinb). 2019 Sep;40:27-33. doi: 10.1016/j.foot.2019.04.001. Epub 2019 Apr 4. PubMed 31055210 ↗
  • Lucas y Hernandez J, Golano P, Roshan-Zamir S, Darcel V, Chauveaux D, Laffenetre O. Treatment of moderate hallux valgus by percutaneous, extra-articular reverse-L Chevron (PERC) osteotomy. Bone Joint J. 2016 Mar;98-B(3):365-73. doi: 10.1302/0301-620X.98B3.35666. PubMed 26920962 ↗
  • Bock P, Kluger R, Kristen KH, Mittlbock M, Schuh R, Trnka HJ. The Scarf Osteotomy with Minimally Invasive Lateral Release for Treatment of Hallux Valgus Deformity: Intermediate and Long-Term Results. J Bone Joint Surg Am. 2015 Aug 5;97(15):1238-45. doi: 10.2106/JBJS.N.00971. PubMed 26246258 ↗
  • Kim HN, Suh DH, Hwang PS, Yu SO, Park YW. Role of intraoperative varus stress test for lateral soft tissue release during chevron bunion procedure. Foot Ankle Int. 2011 Apr;32(4):362-7. doi: 10.3113/FAI.2011.0362. PubMed 21733437 ↗
  • Choi YR, Lee HS, Jeong JJ, Kim SW, Jeon IH, Lee DH, Lee WC. Hallux valgus correction using transarticular lateral release with distal chevron osteotomy. Foot Ankle Int. 2012 Oct;33(10):838-43. doi: 10.3113/FAI.2012.0838. PubMed 23050706 ↗
  • Dalmau-Pastor M, Malagelada F, Cordier G, Del Vecchio JJ, Ghioldi ME, Vega J. Anatomical Study of Minimally Invasive Lateral Release Techniques for Hallux Valgus Treatment. Foot Ankle Int. 2020 Aug;41(8):984-992. doi: 10.1177/1071100720920863. Epub 2020 May 26. PubMed 32456480 ↗
  • Okuda R, Kinoshita M, Yasuda T, Jotoku T, Kitano N, Shima H. Postoperative incomplete reduction of the sesamoids as a risk factor for recurrence of hallux valgus. J Bone Joint Surg Am. 2009 Jul;91(7):1637-45. doi: 10.2106/JBJS.H.00796. PubMed 19571086 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2021; primary completion for Dec 2024, 47 months later.

Of 51 non-industry interventional studies with no phase under Hallux Valgus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's planned 47 months is above that.

Counting every sponsor, half of 56 studies reached it within 26 months; a quarter within 11 and three quarters within 55.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 19, 2020
First posted
Nov 4, 2020
StartEst.
Jan 1, 2021
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2024
Last update
Nov 4, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04614675
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Responsible party
Sponsor
First posted
Nov 4, 2020
Start date
Jan 1, 2021 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Nov 4, 2020

Study contacts

Chao-Ching Chiang, MD
Contact
1966chiang@gmail.com
+886-2-28757557 ext. 140
Chao-Ching Chiang, MD
principal investigator · Taipei Veterans General Hospital, Taiwan

Oversight

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

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