Weightbearing After High Tibial Osteotomy

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426907
• Other study ID #: ON-04-016-TLH
• Status: Completed
• Phase: Phase 4
• First received: January 23, 2007
• Last updated: April 9, 2015
• Start date: January 2007
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Unlimited postoperative weightbearing
Unlimited postoperative weightbearing

Locations

Country	Name	City	State
Denmark	Northern Orthopaedic Division, Klinik Farsoe and Aarhus University Hospital	Farsoe	Northern Jutland

Sponsors (1)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migration in mm measured with RSA (Roentgen Stereometric Analysis):		Postoperative, at 3 month, 1 and 2 years.	No
Secondary	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.	No
Secondary	Hip-Knee-Ankle axis at 3 month, 1 and 2 years postoperative.		Postoperative, at 3 month, 1 and 2 years.	No
Secondary	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.	No