Health TrialsbyHealthPanel

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

ConditionsMedial Compartment OsteoarthritisGenu VarumVarus DeformityHigh Tibial Osteotomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMuhammed Cagatay Engin

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Varus malalignment associated with medial compartment degeneration/osteoarthritis.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Medial HTO Locking Plate

    Device

    Medial Opening Wedge High Tibial Osteotomy.

  • Self-Adjusting HTO External Fixator

    Device

    Medial Opening Wedge High Tibial Osteotomy.

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: Group 1: Plate FixationExperimental treatment 1 intervention
Group B: Group 2: HTO External FixatorActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Radiological Correction (Hip-Knee-Ankle Angle - HKA)

ssessment of the mechanical axis on full-length weight-bearing radiographs (Measured in degrees).

Time frame
Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative.
2

Change in Functional Status (Oxford Knee Score - OKS)

Patient-reported functional score assessing pain and knee function.

Time frame
Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative.
3

Change in Pain Intensity (Visual Analogue Scale - VAS)

Patient-reported pain score from 0 (no pain) to 10 (intolerable pain).

Time frame
Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative

Secondary outcomes

1

Change in Femoro-Tibial Angle (FTA)

Change in the anatomical axis measured in degrees.

Time frame
Baseline (Preoperative) and 12 Months Postoperative.
2

Change in Mechanical Axis Percentage (MA%)

Change in the position of the weight-bearing line on the tibial plateau.

Time frame
Baseline (Preoperative) and 12 Months Postoperative.
3

Change in Posterior Tibial Slope (PTE)

Change in the tibial slope measured in degrees.

Time frame
Baseline (Preoperative) and 12 Months Postoperative.
4

Change in Patellar Height (Insall-Salvati Index)

Change in patellar height measured by the Insall-Salvati ratio.

Time frame
Baseline (Preoperative) and 12 Months Postoperative.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Muhammed Cagatay Engin

Lead sponsor

Ataturk University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: