TO Plate Fixation vs. External Fixator Comparison (HTO Plate vs. ExFix Study)

Condition(s) studied

Investigational drug(s) / intervention(s)

Medial HTO Locking Plate: Medial Opening Wedge High Tibial Osteotomy.

Self-Adjusting HTO External Fixator: Medial Opening Wedge High Tibial Osteotomy.

Study 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.

Eligibility

Primary outcome measure(s)

• Change in Radiological Correction (Hip-Knee-Ankle Angle - HKA) — 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).
• Change in Functional Status (Oxford Knee Score - OKS) — Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative.
  Patient-reported functional score assessing pain and knee function.
• Change in Pain Intensity (Visual Analogue Scale - VAS) — Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative
  Patient-reported pain score from 0 (no pain) to 10 (intolerable pain).

Trial sites (1)

Other trials for the same condition