Osteoarthritis, Knee
Conditions
Keywords
Osteoarthritis, Knee, Osteotomy, Healing, Roentgen Stereometric Analysis
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.
Interventions
PROCEDUREbonesubstitution (Calcibon, Iliac Crest Bonegraft, control)
Osteotomysite are filled with Calcibon (an injectable calcium phosphate cement) or Minced Iliac Crest Bonegraft og local graft as control
Sponsors
Company CCBR A/S
Northern Orthopaedic Division, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Migration in mm measured with RSA (Roentgen Stereometric Analysis) | postoperative, at 3 month, 1 and 2 years |
Secondary
| Measure | Time frame |
|---|---|
| MR of the knee | 4 weeks preoperative, preoperative, at 1 and 2 years postoperative. |
| Markers of chondral degradation | preoperative, at 6 weeks, 3 month, 1 and 2 years postoperative |
| Hip-Knee-Ankle axis | 3 month, 1 and 2 years. |
| Clinical scores: KOOS, Lysholm, SF12, Knee Score | Preoperatively, Postoperatively, 6 weeks, 3 months, 1 year and 2 years |
| Histomorphometric evaluation of bone healing and osseous integration of cement | 1 year |
| Markers of bone synthesis and degradation | preoperative, at 6 weeks, 3 month, 1 and 2 years postoperative |
Countries
Denmark
Outcome results
None listed