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

NCT07212777 | Recruiting

• 1 other identifier: 2025999010604889
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthritis (Knee); Varus Knee

Keywords

patient-specific instrumentation; knee osteotomy; Prospective; Randomised Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Angular precision in AP and lateral planes

  Difference between planned and executed angles in AP and lateral planes

  Immediate postoperative period

• Distance to joint line

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

  Immediate postoperative period

Secondary Outcomes (22)

• Postoperative alignment (HKA angle)

  Immediate postoperative period

• Posterior tibial slope (PTS)

  Immediate postoperative period

• Surgical time

  Day of surgery

• Number of fluoroscopic images

  Day of surgery

• Radiation dose

  Day of surgery

Study Arms (2)

Conventional surgery

ACTIVE COMPARATOR

Osteotomy using conventional technique

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

Patient-specific instrumentation

EXPERIMENTAL

Osteotomy using 3D-printed patient-specific instrumentation

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

Interventions

Medial Open Wedge Hight Tibial Osteotomy using patient-specific instrumentation PROCEDURE

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

Patient-specific instrumentation

Medial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques PROCEDURE

Conventional Medial Open Wedge Hight Tibial Osteotomy

Conventional surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead
• Hospital Universitario Virgen de la Victoria: collaborator

Study Sites (1)

Hospital Universitario Virgen de la Victoria de Málaga

Málaga, Málaga, 29010, Spain

RECRUITING

Related Publications (11)

• 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.

  PMID: 21205966 RESULT

• 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.

  PMID: 31352498 RESULT

• 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.

  PMID: 36585795 RESULT

• 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.

  PMID: 36115179 RESULT

• 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.

  PMID: 32910222 RESULT

• 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.

  PMID: 39881858 RESULT

• 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.

  PMID: 35093132 RESULT

• 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.

  PMID: 31273430 RESULT

• 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.

  PMID: 29986731 RESULT

• 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.

  PMID: 29951264 RESULT

• 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.

  PMID: 39309194 RESULT

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Antonio I Cuesta-Vargas, Prof., PhD

  Universidad de Málaga

  PRINCIPAL INVESTIGATOR

• Juan Miguel Gómez-Palomo, PhD

  Hospital Universitario Virgen de la Victoria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amparo Zamora-Mogollo

CONTACT

+34673662020; amparo.zamora@uma.es

Juan Miguel Gómez Palomo, PhD

CONTACT

jmgomezpalomo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 8, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: November 17, 2025

Record last verified: 2025-09

Locations

ES (1)