Weightbearing After High Tibial Osteotomy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT00426907
First received: January 23, 2007
Last updated: May 1, 2013
Last verified: May 2013

January 23, 2007
May 1, 2013
January 2007
Not Provided
Migration in mm measured with RSA (Roentgen Stereometric Analysis): [ Time Frame: Postoperative, at 3 month, 1 and 2 years. ] [ Designated as safety issue: No ]
  • Migration in mm measured with RSA (Roentgen Stereometric Analysis):
  • postoperative, at 3 month, 1 and 2 years.
Complete list of historical versions of study NCT00426907 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • Hip-Knee-Ankle axis at 3 month, 1 and 2 years postoperative. [ Time Frame: Postoperative, at 3 month, 1 and 2 years. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Clinical scores including range of Movement and muscular status at 6 weeks, 3 month, 1 and 2 years postoperative.
  • Hip-Knee-Ankle axis at 3 month, 1 and 2 years postoperative.
  • Bone Mineral Density (DEXA-scan) pre-op., Post.-op, at 6 weeks, 3 months and 1 and 2 years postop.
Not Provided
Not Provided
 
Weightbearing After High Tibial Osteotomy
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis, Knee
Procedure: Unlimited postoperative weightbearing
Unlimited postoperative weightbearing
  • Experimental: 1
    Full postoperative weightbearing
    Intervention: Procedure: Unlimited postoperative weightbearing
  • Active Comparator: 2
    Partial weightbearing 6 weeks postoperative
    Intervention: Procedure: Unlimited postoperative weightbearing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
July 2010
Not Provided

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00426907
ON-04-016-TLH
No
Northern Orthopaedic Division, Denmark
Northern Orthopaedic Division, Denmark
Not Provided
Principal Investigator: Thomas Lind-Hansen, MD Orthopaedic Division, Northern Denmark Region
Northern Orthopaedic Division, Denmark
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP