Clinical trial NCT00319280: Proximal Tibial Open Wedge Osteotomy. A Clinical Prospective, Randomized RSA-trial.
Official title: Proximal Tibial Open Wedge Osteotomy. Stability and Healing Evaluated in a Clinical Prospective, Randomized Trial Using RSA.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis, Knee
Osteotomy
Healing
Roentgen Stereometric Analysis
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
Collaborators: name: Company CCBR A/S
First posted: 2006-04-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Hitherto the golden standard has been autograft taken from iliac crest but there are donorsite related problems and limited amount available.

Recently injectable and resorbable calciumphosphate-cements have been introduced and used with promising results in fractures of the distal radius, calcaneus and lateral tibial condyle.

These new cements seem to be a good alternative to other bone substitutes providing high initial strength that might promote early mobilisation; it resorbs and promotes osteoconduction securing safe 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 with three different bone substitutes: Autograft from iliac crest and the injectable calciumphosphate-cement Calcibon and as control a group with an empty gap.

Osteosynthesis is performed with the Dynafix® system (EBI) The investigation is performed as a randomised prospective clinical trial including 45 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 is assessed with Roentgen Stereophotogrammetric Analysis (RSA) that provides the opportunity of exact 3-dimensional measuring of eventual loss of correction.

This combined with urine and serum bone-healing markers gives a very precise picture of the healing in the bone-gap.

To asses the cartilage of the knee MRI is performed and biochemical markers fore Collagen type II degradation are measured.


Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of medial compartment of the knee, Ahlbäck gr. 1-2
* Candidate for proximal tibial medial open-wedge osteotomy
* Signed informed consent

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.

Primary outcomes:
measure: Migration in mm measured with RSA (Roentgen Stereometric Analysis)
timeFrame: postoperative, at 3 month, 1 and 2 years
Secondary outcomes:
measure: Hip-Knee-Ankle axis
timeFrame: 3 month, 1 and 2 years.
measure: MR of the knee
timeFrame: 4 weeks preoperative, preoperative, at 1 and 2 years postoperative.
measure: Markers of chondral degradation
timeFrame: preoperative, at 6 weeks, 3 month, 1 and 2 years postoperative
measure: Markers of bone synthesis and degradation
timeFrame: preoperative, at 6 weeks, 3 month, 1 and 2 years postoperative
measure: Clinical scores: KOOS, Lysholm, SF12, Knee Score
timeFrame: Preoperatively, Postoperatively, 6 weeks, 3 months, 1 year and 2 years
measure: Histomorphometric evaluation of bone healing and osseous integration of cement
timeFrame: 1 year
Other outcomes:
Locations:
city: Farsoe
country: Denmark
facility: Northern Orthopaedic Division, Klinik Farsoe, Aalborg University Hospital
state: Northern Jutland
Study officials:
affiliation: Northern Orthopaedic Division, Denmark
name: Thomas Lind-Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References: