Medial Opening Wedge High Tibial Osteotomy: A Comparative Study of Plate Fixation and Self-Adjusting HTO External Fixator Techniques
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Change in Pain Intensity (Visual Analogue Scale - VAS)
Study Overview
Brief Summary
This study aims to compare the efficacy, accuracy, and functional outcomes of two different surgical stabilization techniques for medial opening wedge high tibial osteotomy (HTO) in patients with varus deformity and medial compartment osteoarthritis. Patients will be prospectively randomized into two groups: Group 1 (Plate Fixation) will receive acute (single-stage) correction and stabilization with a medial HTO locking plate. Group 2 (HTO External Fixator) will receive stabilization using a self-adjusting HTO external fixator, followed by gradual correction (hemicallotasis/distraction) starting 7 days post-operatively. The study will evaluate radiological correction, functional improvement (using the Oxford Knee Score), and complication rates over a 12-month follow-up period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Varus malalignment associated with medial compartment degeneration/osteoarthritis.
- •Indication for Medial Opening Wedge HTO. Aged 18 years or older. Willing to participate in the study and provide written informed consent.
Exclusion Criteria
- •Advanced-stage osteoarthritis (Indication for Total Knee Arthroplasty). Previous open knee surgery on the same extremity. Inability to comply with follow-up appointments. Significant comorbidities (e.g., uncontrolled diabetes, rheumatoid arthritis).
Arms & Interventions
Group 1: Plate Fixation
The osteotomy will be acutely corrected intraoperatively and stabilized using a Medial High Tibial locking plate.
Intervention: Medial HTO Locking Plate (Device)
Group 2: HTO External Fixator
he osteotomy will be stabilized using a Self-Adjusting HTO External Fixator. Gradual distraction (hemicallotasis) will begin 7 days post-operatively at a rate of 1 mm per day to achieve correction.
Intervention: Self-Adjusting HTO External Fixator (Device)
Outcomes
Primary Outcomes
Change in Pain Intensity (Visual Analogue Scale - VAS)
Time Frame: Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative
Patient-reported pain score from 0 (no pain) to 10 (intolerable pain).
Change in Functional Status (Oxford Knee Score - OKS)
Time Frame: Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative.
Patient-reported functional score assessing pain and knee function.
Change in Radiological Correction (Hip-Knee-Ankle Angle - HKA)
Time Frame: Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative.
ssessment of the mechanical axis on full-length weight-bearing radiographs (Measured in degrees).
Secondary Outcomes
- Change in Femoro-Tibial Angle (FTA)(Baseline (Preoperative) and 12 Months Postoperative.)
- Change in Mechanical Axis Percentage (MA%)(Baseline (Preoperative) and 12 Months Postoperative.)
- Change in Posterior Tibial Slope (PTE)(Baseline (Preoperative) and 12 Months Postoperative.)
- Change in Patellar Height (Insall-Salvati Index)(Baseline (Preoperative) and 12 Months Postoperative.)
- Incidence of Complications(Up to 12 months postoperative.)
Investigators
Muhammed Cagatay Engin
Associate Professor
Ataturk University