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RecruitingNCT07212777AMBE_ORUpdated Jul 22, 2026

Precision of Pacient-specific Instrumented Open Wedge High Tibial Osteotomy vs Conventional Technicque

An interventional study of Medial Open Wedge Hight Tibial Osteotomy using patient-specific instrumentation and Medial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques in Arthritis (Knee) and Varus Knee, sponsored by University of Malaga. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by University of Malaga · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This study is a randomized clinical trial that will compare two surgical techniques for patients with knee osteoarthritis and varus deformity who are candidates for medial opening wedge high tibial osteotomy. The goal is to evaluate whether using patient-specific 3D-printed surgical guides improves the accuracy of the bone cut compared with the conventional technique performed with anatomical landmarks and fluoroscopy.

A total of 50 adult patients will be randomly assigned to one of two groups: conventional osteotomy or osteotomy assisted by patient-specific instrumentation (PSI). The main outcome is the accuracy of the osteotomy cut, measured by comparing preoperative planning with the postoperative CT scan. Secondary outcomes include leg alignment, surgical time, radiation exposure, complications, and functional recovery assessed with validated questionnaires (KOOS, WOMAC, IKDC, EQ-5D) and gait analysis using depth cameras.

Patients will be followed for up to 12 months after surgery to evaluate clinical and radiological outcomes.

Read the detailed description

Medial opening wedge high tibial osteotomy is a well-established surgical procedure to correct knee alignment in patients with medial knee osteoarthritis and varus deformity. The accuracy of the bone cut is critical for surgical success. However, conventional techniques performed with anatomical landmarks and fluoroscopy may result in variability and suboptimal correction.

Recent advances in 3D imaging and printing allow the creation of patient-specific surgical guides designed from preoperative CT scans. These guides may improve the accuracy and reproducibility of the osteotomy.

This single-center randomized clinical trial will include 50 adult patients, randomly assigned to undergo conventional osteotomy or osteotomy assisted by patient-specific instrumentation. The main outcome is the accuracy of the osteotomy cut compared with preoperative planning. Secondary outcomes include leg alignment, surgical efficiency, radiation exposure, complications, and functional recovery. Patients will be followed for 12 months.

02

Conditions studied

  • Arthritis (Knee)
  • Varus Knee

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Keywords

  • patient-specific instrumentation
  • knee osteotomy
  • Prospective
  • Randomised Controlled Trial
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Informed consent: able to sign informed consent
  • Clinical: predominantly medial pain/limitation refractory ≥3-6 months
  • Mobility: flexion ≥90º and flexion contracture ≤10º Stability: varus/valgus and pivot-shift ≤ grade 1.

  • Radiology:

    • Medial gonarthrosis Ahlbäck I-III with preserved lateral compartment.
    • Patellofemoral Iwano 0-2 without disabling patellofemoral pain.
    • Varus alignment: HKA 4-10°.
    • Predominantly tibial deformity (decreased MPTA; LDFA close to normal) according to planning.
  • Anatomy/technical feasibility: proximal tibial morphology suitable for medial opening osteotomy and PSI guide placement.

Exclusion criteria

Exclusion criteria:

  • Comorbidity/clinical situations:

    • Inflammatory arthritis (e.g., RA, spondyloarthropathies), unresolved previous joint infection or osteomyelitis.
    • Severe peripheral vasculopathy (ABI \<0.7), advanced peripheral neuropathy or Charcot foot.
    • Poorly controlled diabetes (HbA1c >8.5%), advanced renal/hepatic failure (eGFR \<30 ml/min/1.73 m²; Child-Pugh B/C).
    • Smoking >20 cigarettes/day without commitment to cessation; active IV drug use or uncontrolled alcoholism.
    • BMI >35 kg/m².
    • Disorder affecting gait (e.g., neurological disease).
    • Inability to walk at a speed of at least 0.8m/s

  • Anatomy/radiology

    • Multiplanar deformities not correctable with isolated medial opening tibial valgus osteotomy (e.g., dominant femoral deformity).
    • Severe medial subchondral bone defect or extensive necrosis.
    • Sequelae of proximal tibia fracture or previous ipsilateral HTO that prevent correction or guide use.

  • Treatments/medication and logistics

    • Anticoagulation/antiplatelet therapy that cannot be suspended or bridged.
    • Systemic corticosteroids >10 mg/day or high-risk immunosuppressants without possibility of adjustment.
    • Intra-articular infiltration (HA/CS/PRP) within the previous 60 days (respect defined wash-out).
    • Pregnancy.
    • Participation in another interfering trial.
    • Inability to undergo CT (e.g., uncontrollable claustrophobia).
    • Inability to complete ≥12 months of follow-up.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Conventional surgery

    Osteotomy using conventional technique

    Procedure: Medial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques

  • Experimental
    Patient-specific instrumentation

    Osteotomy using 3D-printed patient-specific instrumentation

    Procedure: Medial Open Wedge Hight Tibial Osteotomy using patient-specific instrumentation

Interventions

  • ProcedureMedial Open Wedge Hight Tibial Osteotomy using patient-specific instrumentation

    Medial Open Wedge Hight Tibial Osteotomy using 3D printed patient-specific instrumentation as a guide for the osteotomy

  • ProcedureMedial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques

    Conventional Medial Open Wedge Hight Tibial Osteotomy

05

What researchers measure

Primary outcomes

  1. Angular precision in AP and lateral planes

    Difference between planned and executed angles in AP and lateral planes

    Time frame: Immediate postoperative period

  2. Distance to joint line

    Difference between planned and executed distance between osteotomy cut and and joint line

    Time frame: Immediate postoperative period

Secondary outcomes

  1. Postoperative alignment (HKA angle)

    Difference between planned and achieved hip-knee-ankle angle

    Time frame: Immediate postoperative period

  2. Posterior tibial slope (PTS)

    Difference between planned and achieved tibial slope

    Time frame: Immediate postoperative period

  3. Surgical time

    Duration from skin incision to closure

    Time frame: Day of surgery

  4. Number of fluoroscopic images

    Total intraoperative fluoroscopy shots

    Time frame: Day of surgery

  5. Radiation dose

    Cumulative radiation exposure during surgery (mGy)

    Time frame: Day of surgery

  6. Intraoperative complications

    Events such as hinge fracture or neurovascular injury

    Time frame: Day of surgery

  7. Postoperative complications

    Infection, delayed bone healing, thrombotic events

    Time frame: From surgery to end of 12 month follow-up

  8. Reoperation

    Need for additional surgical intervention

    Time frame: From surgery to end of 12 month follow-up

  9. Functional recovery

    Time to full weight-bearing without assistance

    Time frame: From surgery to end of 12 month follow-up

  10. Radiographic consolidation

    Time to radiographic evidence of bone healing

    Time frame: From surgery until the end of the 12 month follow-up

  11. 5 Sit to Stand Test

    Time it takes the patient to perform 5 sit to stands

    Time frame: From surgery until the end of the 12 month follow-up

  12. Visual Analog Scale (VAS for pain)

    Range 0-10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse outcome.

    Time frame: From surgery until the end of the 12 month follow-up

  13. Percentage of patients with a +-2º correction within the planned osteotomy

    Precision of the alignment of the knee with respect tot he planned osteotomy

    Time frame: Immediate postoperative period

  14. Timed-Up-and-Go

    Time that it takes the patient to stand up from a chair and walk 10 meters, turn 180º and return to the starting position

    Time frame: From surgery until the end of the 12 month follow-up

  15. Balance Test (from the Short Physical Performance Battery, SPPB)

    The balance component of the Short Physical Performance Battery (SPPB) assesses the ability to maintain three standing positions: feet together, semi-tandem, and tandem stand, each for up to 10 seconds. The test is scored from 0 to 4, where 0 = unable to hold any position, and 4 = able to hold the tandem position for 10 seconds. Higher scores indicate better balance performance.

    Time frame: From surgery to end of 12 month follow-up

  16. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Each subscale scored from 0-100, where 0 = extreme problems and 100 = no problems. Higher scores indicate better outcome.

    Time frame: From surgery to end of 12 month follow-up

  17. International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form

    Score range 0-100, where 0 = worst knee function and 100 = no limitations. Higher scores indicate better outcome.

    Time frame: From surgery to end of 12 month follow-up

  18. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Scored 0-96, where higher scores indicate worse pain, stiffness, and physical function.

    Time frame: From surgery to end of 12 month follow-up

  19. EuroQol 5 Dimensions Questionnaire (EQ-5D-5L)

    Index score range usually from -0.59 (worst health state) to 1 (perfect health); higher scores indicate better quality of life.

    Time frame: From surgery to end of 12 month follow-up

  20. Lower Limb Functional Index (LLFI)

    Patient-reported questionnaire that measures lower limb functional status. It consists of 25 items scored as "yes" (1 point), "sometimes" (0.5 points), or "no" (0 points). The raw score is summed and converted to a percentage (0-100). Higher scores indicate greater disability, while lower scores indicate better functional status. Ranges from 0-100. Higher scores mean a worse outcome.

    Time frame: From surgery to end of 12 month follow-up

  21. Foot Health Status Questionnaire (FHSQ)

    Patient-reported questionnaire assessing foot health across several domains: pain, function, footwear, and general foot health. Each domain score is transformed to a 0-100 scale. Higher scores indicate better foot health and function. Range: 0-100 for each domain. Higher scores mean a better outcome.

    Time frame: From surgery to end of 12 month follow-up

  22. Foot Function Index (FFI)

    Patient-reported measure assessing foot pain, disability, and activity limitation. Contains 23 items scored on a visual analog scale (0-10). The total score is normalized to a 0-100 scale. Higher scores indicate greater pain, disability, and activity limitation. Range: 0-100. Higher scores mean a worse outcome.

    Time frame: From surgery to end of 12 month follow-up

06

Study locations

1 of 1 sites recruiting
  • Hospital Universitario Virgen de la Victoria de Málaga
    Málaga, Málaga 29010, Spain
    Recruiting
07

References and documents

Publications

  • Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923. PubMed 21205966 ↗
  • Jacquet C, Sharma A, Fabre M, Ehlinger M, Argenson JN, Parratte S, Ollivier M. Patient-specific high-tibial osteotomy's 'cutting-guides' decrease operating time and the number of fluoroscopic images taken after a Brief Learning Curve. Knee Surg Sports Traumatol Arthrosc. 2020 Sep;28(9):2854-2862. doi: 10.1007/s00167-019-05637-6. Epub 2019 Jul 27. PubMed 31352498 ↗
  • Pang R, Jiang Z, Xu C, Shi W, Zhang X, Wan X, Bahat D, Li H, Senatov F, Bulygina I, Wang H, Zhang H, Li Z. Is Patient-Specific Instrumentation Accurate and Necessary for Open-Wedge High Tibial Osteotomy? A Meta-Analysis. Orthop Surg. 2023 Feb;15(2):413-422. doi: 10.1111/os.13483. Epub 2022 Dec 30. PubMed 36585795 ↗
  • Zhu X, Qian Y, Liu A, Xu P, Guo JJ. Comparative outcomes of patient-specific instrumentation, the conventional method and navigation assistance in open-wedge high tibial osteotomy: A prospective comparative study with a two-year follow up. Knee. 2022 Dec;39:18-28. doi: 10.1016/j.knee.2022.08.013. Epub 2022 Sep 14. PubMed 36115179 ↗
  • Cerciello S, Ollivier M, Corona K, Kaocoglu B, Seil R. CAS and PSI increase coronal alignment accuracy and reduce outliers when compared to traditional technique of medial open wedge high tibial osteotomy: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2022 Feb;30(2):555-566. doi: 10.1007/s00167-020-06253-5. Epub 2020 Sep 10. PubMed 32910222 ↗
  • Carey EG, Kamath AF, Vidal AF, Frush T, Alaia M, Baldwin RB, Ranawat A. Assessing the Impact of Patient-Specific Instrumentation and Fixation on Accuracy and Radiation Exposure in a Cadaveric Model of Medial Opening-Wedge High Tibial Osteotomy. Orthop J Sports Med. 2025 Jan 28;13(1):23259671241285430. doi: 10.1177/23259671241285430. eCollection 2025 Jan. PubMed 39881858 ↗
  • Miao Z, Li S, Luo D, Lu Q, Liu P. The validity and accuracy of 3D-printed patient-specific instruments for high tibial osteotomy: a cadaveric study. J Orthop Surg Res. 2022 Jan 29;17(1):62. doi: 10.1186/s13018-022-02956-2. PubMed 35093132 ↗
  • Chaouche S, Jacquet C, Fabre-Aubrespy M, Sharma A, Argenson JN, Parratte S, Ollivier M. Patient-specific cutting guides for open-wedge high tibial osteotomy: safety and accuracy analysis of a hundred patients continuous cohort. Int Orthop. 2019 Dec;43(12):2757-2765. doi: 10.1007/s00264-019-04372-4. Epub 2019 Jul 5. PubMed 31273430 ↗
  • Donnez M, Ollivier M, Munier M, Berton P, Podgorski JP, Chabrand P, Parratte S. Are three-dimensional patient-specific cutting guides for open wedge high tibial osteotomy accurate? An in vitro study. J Orthop Surg Res. 2018 Jul 9;13(1):171. doi: 10.1186/s13018-018-0872-4. PubMed 29986731 ↗
  • Jones GG, Jaere M, Clarke S, Cobb J. 3D printing and high tibial osteotomy. EFORT Open Rev. 2018 May 21;3(5):254-259. doi: 10.1302/2058-5241.3.170075. eCollection 2018 May. PubMed 29951264 ↗
  • Stimolo D, Leggieri F, Matassi F, Barra A, Civinini R, Innocenti M. Learning curves for high tibial osteotomy using patient-specific instrumentation: a case control study. Innov Surg Sci. 2024 Jul 3;9(3):123-131. doi: 10.1515/iss-2024-0007. eCollection 2024 Sep. PubMed 39309194 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT07212777
Lead sponsor
University of Malaga
Collaborators
Hospital Universitario Virgen de la Victoria
Responsible party
Dr. Antonio I Cuesta-Vargas (Full Professor, University of Malaga) — Principal investigator
First posted
Oct 8, 2025
Start date
Nov 15, 2025
Primary completion
Sep 2027 (estimated)
Completion
Oct 2028 (estimated)
Last update
Jul 22, 2026

Study contacts

Amparo Zamora-Mogollo
Contact
amparo.zamora@uma.es
+34673662020
Juan Miguel Gómez Palomo, PhD
Contact
jmgomezpalomo@gmail.com
Antonio I Cuesta-Vargas, Prof., PhD
principal investigator · Universidad de Málaga
Juan Miguel Gómez-Palomo, PhD
principal investigator · Hospital Universitario Virgen de la Victoria

Oversight

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

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