Weightbearing After High Tibial Osteotomy - Full Text View

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 IV

MedlinePlus related topics:

Osteoarthritis Rehabilitation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Weightbearing After Proximal Open-Wedge Tibial Osteotomy - a Clinical, Randomized RSA-Study.

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:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Full postoperative weightbearing	Procedure: Unlimited postoperative weightbearing Unlimited postoperative weightbearing
2: Active Comparator 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

Contacts


Contact: Thomas Lind-Hansen, MD	+45 98124038	tblh@rn.dk

Locations


Denmark, Northern Jutland
	Northern Orthopaedic Division, Klinik Farsoe and Aarhus University Hospital	Recruiting
	Farsoe, Northern Jutland, Denmark
	Contact: Thomas Lind-Hansen, MD tblh@rn.dk
	Principal Investigator: Thomas Lind-Hansen, MD

Sponsors and Collaborators

Northern Orthopaedic Division, Denmark

Investigators


Principal Investigator:	Thomas Lind-Hansen, MD	Orthopaedic Division, Northern Denmark Region

More Information

Responsible Party:	Northern Orthopaedic Division, Denmark ( Thomas Lind-Hansen )
Study ID Numbers:	ON-04-016-TLH
First Received:	January 23, 2007
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00426907
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Northern Orthopaedic Division, Denmark:

Osteoarthritis, Knee

Osteotomy

Healing

Rehabilitation

Roentgen Stereometric Analysis

Study placed in the following topic categories:

Osteoarthritis, Knee

Musculoskeletal Diseases

Osteoarthritis

Joint Diseases

Arthritis

Rheumatic Diseases

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Northern Orthopaedic Division, Denmark
Information provided by:	Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:	NCT00426907