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NCT Number: NCT00426907

Weightbearing After High Tibial Osteotomy

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northern Orthopaedic Division, Klinik Farsoe and Aarhus University Hospital

Farsø, Northern Jutland, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Unlimited postoperative weightbearing

Procedure

Unlimited postoperative weightbearing

Primary outcomes

  1. Migration in mm measured with RSA (Roentgen Stereometric Analysis):

    Time frame: Postoperative, at 3 month, 1 and 2 years.

Secondary outcomes

  1. 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.

  2. Hip-Knee-Ankle axis at 3 month, 1 and 2 years postoperative.

    Time frame: Postoperative, at 3 month, 1 and 2 years.

  3. 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.

Sponsors and collaborators

Lead sponsor

Northern Orthopaedic Division, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Jan 25, 2007
Registry last updated
Apr 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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