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
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.
843 studies on the registry are indexed under Arthritis; 118 are open to participants now.
This study's planned enrollment of 50 is below the median of 97 across 599 interventional studies indexed under Arthritis.
Browse Arthritis studies →University of Malaga is the lead sponsor of 121 studies on the registry; 34 are open to participants now.
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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.
Radiology:
Exclusion criteria:
Comorbidity/clinical situations:
Anatomy/radiology
Treatments/medication and logistics
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Osteotomy using conventional technique
Procedure: Medial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques
Osteotomy using 3D-printed patient-specific instrumentation
Procedure: 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
Conventional Medial Open Wedge Hight Tibial Osteotomy
Angular precision in AP and lateral planes
Difference between planned and executed angles in AP and lateral planes
Time frame: Immediate postoperative period
Distance to joint line
Difference between planned and executed distance between osteotomy cut and and joint line
Time frame: Immediate postoperative period
Postoperative alignment (HKA angle)
Difference between planned and achieved hip-knee-ankle angle
Time frame: Immediate postoperative period
Posterior tibial slope (PTS)
Difference between planned and achieved tibial slope
Time frame: Immediate postoperative period
Surgical time
Duration from skin incision to closure
Time frame: Day of surgery
Number of fluoroscopic images
Total intraoperative fluoroscopy shots
Time frame: Day of surgery
Radiation dose
Cumulative radiation exposure during surgery (mGy)
Time frame: Day of surgery
Intraoperative complications
Events such as hinge fracture or neurovascular injury
Time frame: Day of surgery
Postoperative complications
Infection, delayed bone healing, thrombotic events
Time frame: From surgery to end of 12 month follow-up
Reoperation
Need for additional surgical intervention
Time frame: From surgery to end of 12 month follow-up
Functional recovery
Time to full weight-bearing without assistance
Time frame: From surgery to end of 12 month follow-up
Radiographic consolidation
Time to radiographic evidence of bone healing
Time frame: From surgery until the end of the 12 month follow-up
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
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
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
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
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
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
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
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
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
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
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
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
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