Clinical trial NCT00426907: Weightbearing After High Tibial Osteotomy
Official title: Weightbearing After Proximal Open-wedge Tibial Osteotomy - a Clinical, Randomized RSA-study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis, Knee
Osteotomy
Healing
Rehabilitation
Roentgen Stereometric Analysis
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2007-01-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Migration in mm measured with RSA (Roentgen Stereometric Analysis):
timeFrame: Postoperative, at 3 month, 1 and 2 years.
Secondary outcomes:
measure: Clinical scores including range of Movement and muscular status at 6 weeks, 3 month, 1 and 2 years postoperative.
timeFrame: Postoperative, at 3 month, 1 and 2 years.
measure: Hip-Knee-Ankle axis at 3 month, 1 and 2 years postoperative.
timeFrame: Postoperative, at 3 month, 1 and 2 years.
measure: Bone Mineral Density (DEXA-scan) pre-op., Post.-op, at 6 weeks, 3 months and 1 and 2 years postop.
timeFrame: Postoperative, at 3 month, 1 and 2 years.
Other outcomes:
Locations:
city: Farsoe
country: Denmark
facility: Northern Orthopaedic Division, Klinik Farsoe and Aarhus University Hospital
state: Northern Jutland
Study officials:
affiliation: Orthopaedic Division, Northern Denmark Region
name: Thomas Lind-Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References: