Weightbearing After High Tibial Osteotomy

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00426907

Enrollment

Registered

2007-01-25

Start date

2007-01-31

Completion date

2014-09-30

Last updated

2015-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, Knee, Osteotomy, Healing, Rehabilitation, Roentgen Stereometric Analysis

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.

Interventions

PROCEDUREUnlimited postoperative weightbearing

Unlimited postoperative weightbearing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.
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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026