Precision of Pacient-specific Instrumented Open Wedge High Tibial Osteotomy vs Conventional Technicque
NCT ID: NCT07212777
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
50 participants
INTERVENTIONAL
2025-11-15
2028-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
High Tibial Osteotomy for Osteoarthritis of the Knee
NCT01977261
Time-dependent Functional Results Following HTO. Closing Wedge vs Opening Wedge Technique.
NCT01797003
A Modified (Retro-Tubercle) Opening Wedge High Tibial Osteotomy Versus the Conventional Technique
NCT01122017
Finding the Optimal Aim of Correction in Opening Wedge High Tibial Osteotomy
NCT06134050
Clinical and Radiographic Outcomes of Medial Open-wedge High Tibial Osteotomy
NCT04036266
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Conventional surgery
Osteotomy using conventional technique
Medial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques
Conventional Medial Open Wedge Hight Tibial Osteotomy
Patient-specific instrumentation
Osteotomy using 3D-printed patient-specific instrumentation
Medial 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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Medial 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
Medial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques
Conventional Medial Open Wedge Hight Tibial Osteotomy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Universitario Virgen de la Victoria
OTHER
University of Malaga
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Antonio I Cuesta-Vargas
Full Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Antonio I Cuesta-Vargas, Prof., PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad de Málaga
Juan Miguel Gómez-Palomo, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Virgen de la Victoria
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Universitario Virgen de la Victoria de Málaga
Málaga, Málaga, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025999010604889
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.