Weightbearing After High Tibial Osteotomy

NCT ID: NCT00426907

Last Updated: 2015-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2014-09-30

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Full postoperative weightbearing

Group Type: EXPERIMENTAL

Unlimited postoperative weightbearing

Intervention Type: PROCEDURE

Unlimited postoperative weightbearing

2

Partial weightbearing 6 weeks postoperative

Group Type: ACTIVE_COMPARATOR

Unlimited postoperative weightbearing

Intervention Type: PROCEDURE

Unlimited postoperative weightbearing

Interventions

Unlimited postoperative weightbearing

Unlimited postoperative weightbearing

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northern Orthopaedic Division, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Lind-Hansen, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Division, Northern Denmark Region

Locations

Northern Orthopaedic Division, Klinik Farsoe and Aarhus University Hospital

Farsø, Northern Jutland, Denmark

Countries

Denmark

Other Identifiers

ON-04-016-TLH

Identifier Type: -

Identifier Source: org_study_id