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| Name | Class |
|---|---|
| Hospital Universitario Virgen de la Victoria | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional surgery | Active Comparator | Osteotomy using conventional technique |
|
| Patient-specific instrumentation | Experimental | Osteotomy using 3D-printed patient-specific instrumentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative alignment (HKA angle) | Difference between planned and achieved hip-knee-ankle angle | Immediate postoperative period |
| Posterior tibial slope (PTS) | Difference between planned and achieved tibial slope |
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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:
Anatomy/technical feasibility: proximal tibial morphology suitable for medial opening osteotomy and PSI guide placement.
Exclusion criteria:
Comorbidity/clinical situations:
Anatomy/radiology
Treatments/medication and logistics
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amparo Zamora-Mogollo | Contact | +34673662020 | amparo.zamora@uma.es | |
| Juan Miguel Gómez Palomo, PhD | Contact | jmgomezpalomo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Antonio I Cuesta-Vargas, Prof., PhD | Universidad de Málaga | Principal Investigator |
| Juan Miguel Gómez-Palomo, PhD | Hospital Universitario Virgen de la Victoria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen de la Victoria de Málaga | Recruiting | Málaga | 29010 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21205966 | Result | 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. | |
| 31352498 | Result |
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| Medial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques | Procedure | Conventional Medial Open Wedge Hight Tibial Osteotomy |
|
| Immediate postoperative period |
| Surgical time | Duration from skin incision to closure | Day of surgery |
| Number of fluoroscopic images | Total intraoperative fluoroscopy shots | Day of surgery |
| Radiation dose | Cumulative radiation exposure during surgery (mGy) | Day of surgery |
| Intraoperative complications | Events such as hinge fracture or neurovascular injury | Day of surgery |
| Postoperative complications | Infection, delayed bone healing, thrombotic events | From surgery to end of 12 month follow-up |
| Reoperation | Need for additional surgical intervention | From surgery to end of 12 month follow-up |
| Functional recovery | Time to full weight-bearing without assistance | From surgery to end of 12 month follow-up |
| Radiographic consolidation | Time to radiographic evidence of bone healing | From surgery until the end of the 12 month follow-up |
| 30 Sit to Stand Test | Amount of sit-to-stands that can be achieved by the patient in a 30 second window | From surgery until the end of the 12 month follow-up |
| Visual Analog Scale (VAS for pain) | Range 0-10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse outcome. | From surgery until the end of the 12 month follow-up |
| Percentage of patients with a +-2º correction within the planned osteotomy | Precision of the alignment of the knee with respect tot he planned osteotomy | Immediate postoperative period |
| 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 | From surgery until the end of the 12 month follow-up |
| 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. | From surgery to end of 12 month follow-up |
| 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. | From surgery to end of 12 month follow-up |
| 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. | From surgery to end of 12 month follow-up |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Scored 0-96, where higher scores indicate worse pain, stiffness, and physical function. | From surgery to end of 12 month follow-up |
| 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. | From surgery to end of 12 month follow-up |
| 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. | From surgery to end of 12 month follow-up |
| 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. | From surgery to end of 12 month follow-up |
| 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. | From surgery to end of 12 month follow-up |
| 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. |
| 36585795 | 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. |
| 36115179 | 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. |
| 32910222 | 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. |
| 39881858 | 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. |
| 35093132 | 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. |
| 31273430 | 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. |
| 29986731 | 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. |
| 29951264 | 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. |
| 39309194 | 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. |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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