Weightbearing After High Tibial Osteotomy

Phase 4

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Procedure: Unlimited postoperative weightbearing

• Registration Number: NCT00426907
• Lead Sponsor: Northern Orthopaedic Division, Denmark

Brief Summary

In this project we want investigate the clinical results after different rehabilitation regimens(Limited or unlimited weightbearing after surgery) in Open-wedge High Tibial Osteotomies.

The hypothesis is that unlimited weightbearing is beneficial for the healing and rehabilitation.

Detailed Description

In the treatment of osteoarthritis of the medial compartment of the knee, Open wedge high tibial osteotomy is a good choice of treatment for the young and active patient.

However it leaves an open gap which has to be filled with a bone substitute and requires stable fixation.

Different rehabilitation-regimens are described, many advocating a period of partial weight-bearing for a period after surgery.

Results from biomechanical studies suggest that immediate full weight-bearing is safe, enabling earlier mobilisation without compromising safe solid healing.

The aim of the present study is to evaluate whether there is any difference in clinical outcome, correction, stability and healing in open-wedge osteotomies (osteosynthesis with the Dynafix® system (EBI)) after 2 different rehabilitation regimens: Limited weight-bearing (20 kg) for 6 weeks, and unrestricted weight-bearing.

The investigation is performed as a randomised prospective clinical trial including 20 patients with a planned 2 years follow-up period.

Clinical outcome is evaluated with: Hospital of special surgery score, KOOS, SF 12 and Lysholm score.

Routine standing x-rays is performed. Stability of the osteotomy is assessed with Roentgen Stereophotogrammetric Analysis (RSA) that provides the opportunity of exact 3-dimensional measuring of eventual loss of correction.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-23
• Study First Submitted QC: 2007-01-23
• Study First Posted: 2007-01-25
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Signed informed consent
• Osteoarthritis of medial compartment of the knee, Ahlbäck gr. 1-2
• Varus deformity

Exclusion Criteria

• Prednisolone treatment.
• NSAID treatment.
• BMI > or = 35.
• Previous surgery in lateral knee compartment.
• Secondary Arthrosis following fracture(s) of the tibial condyle(s).
• Lack of informed consent.
• Correction >12,5 mm
• Peroperative displaced fracture of lateral bony hinge.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Unlimited postoperative weightbearing	Partial weightbearing 6 weeks postoperative
1	Unlimited postoperative weightbearing	Full postoperative weightbearing

Primary Outcome Measures

Name	Time	Method
Migration in mm measured with RSA (Roentgen Stereometric Analysis):	Postoperative, at 3 month, 1 and 2 years.

Secondary Outcome Measures

Name	Time	Method
Bone Mineral Density (DEXA-scan) pre-op., Post.-op, at 6 weeks, 3 months and 1 and 2 years postop.	Postoperative, at 3 month, 1 and 2 years.
Clinical scores including range of Movement and muscular status at 6 weeks, 3 month, 1 and 2 years postoperative.	Postoperative, at 3 month, 1 and 2 years.
Hip-Knee-Ankle axis at 3 month, 1 and 2 years postoperative.	Postoperative, at 3 month, 1 and 2 years.

Trial Locations

Locations (1)

Northern Orthopaedic Division, Klinik Farsoe and Aarhus University Hospital; 🇩🇰 Farsoe, Northern Jutland, Denmark