Weightbearing After High Tibial Osteotomy

April 9, 2015 updated by: Northern Orthopaedic Division, Denmark

Weightbearing After Proximal Open-wedge Tibial Osteotomy - a Clinical, Randomized RSA-study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Northern Jutland
      • Farsoe, Northern Jutland, Denmark
        • Northern Orthopaedic Division, Klinik Farsoe and Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Full postoperative weightbearing
Procedure: Unlimited postoperative weightbearing
Unlimited postoperative weightbearing
Active Comparator: 2
Partial weightbearing 6 weeks postoperative
Procedure: Unlimited postoperative weightbearing
Unlimited postoperative weightbearing

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Orthopaedic Division, Denmark

Investigators

  • Principal Investigator: Thomas Lind-Hansen, MD, Orthopaedic Division, Northern Denmark Region

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

January 23, 2007

First Submitted That Met QC Criteria

January 23, 2007

First Posted (Estimate)

January 25, 2007

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ON-04-016-TLH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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