Weightbearing After High Tibial Osteotomy
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Unlimited postoperative weightbearing
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee, Osteotomy, Healing, Rehabilitation, Roentgen Stereometric Analysis
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.
Sites / Locations
- Northern Orthopaedic Division, Klinik Farsoe and Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Full postoperative weightbearing
Partial weightbearing 6 weeks postoperative
Outcomes
Primary Outcome Measures
Migration in mm measured with RSA (Roentgen Stereometric Analysis):
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00426907
First Posted
January 23, 2007
Last Updated
April 9, 2015
Sponsor
Northern Orthopaedic Division, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT00426907
Brief Title
Weightbearing After High Tibial Osteotomy
Official Title
Weightbearing After Proximal Open-wedge Tibial Osteotomy - a Clinical, Randomized RSA-study.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern Orthopaedic Division, Denmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, Knee, Osteotomy, Healing, Rehabilitation, Roentgen Stereometric Analysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Full postoperative weightbearing
Arm Title
2
Arm Type
Active Comparator
Arm Description
Partial weightbearing 6 weeks postoperative
Intervention Type
Procedure
Intervention Name(s)
Unlimited postoperative weightbearing
Intervention Description
Unlimited postoperative weightbearing
Primary Outcome Measure Information:
Title
Migration in mm measured with RSA (Roentgen Stereometric Analysis):
Time Frame
Postoperative, at 3 month, 1 and 2 years.
Secondary Outcome Measure Information:
Title
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.
Title
Hip-Knee-Ankle axis at 3 month, 1 and 2 years postoperative.
Time Frame
Postoperative, at 3 month, 1 and 2 years.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Lind-Hansen, MD
Organizational Affiliation
Orthopaedic Division, Northern Denmark Region
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern Orthopaedic Division, Klinik Farsoe and Aarhus University Hospital
City
Farsoe
State/Province
Northern Jutland
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Weightbearing After High Tibial Osteotomy
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