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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Knee
 Procedure: Unlimited postoperative weightbearing
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Weightbearing After Proximal Open-wedge Tibial Osteotomy - a Clinical, Randomized RSA-study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • Migration in mm measured with RSA (Roentgen Stereometric Analysis): [ Time Frame: Postoperative, at 3 month, 1 and 2 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: January 2007
Estimated Study Completion Date: July 2010
Arms Assigned Interventions
Experimental: 1
Full postoperative weightbearing
 Procedure: Unlimited postoperative weightbearing
Unlimited postoperative weightbearing
Active Comparator: 2
Partial weightbearing 6 weeks postoperative
 Procedure: Unlimited postoperative weightbearing
Unlimited postoperative weightbearing

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426907

Locations
Denmark
Northern Orthopaedic Division, Klinik Farsoe and Aarhus University Hospital
Farsoe, Northern Jutland, Denmark
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Investigators
Principal Investigator: Thomas Lind-Hansen, MD Orthopaedic Division, Northern Denmark Region
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT00426907     History of Changes
Other Study ID Numbers: ON-04-016-TLH
Study First Received: January 23, 2007
Last Updated: May 1, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
Osteoarthritis, Knee
Osteotomy
Healing
Rehabilitation
Roentgen Stereometric Analysis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013