Proximal Tibial Open Wedge Osteotomy. A Clinical Prospective, Randomized RSA-trial.

NCT ID: NCT00319280

Last Updated: 2014-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2008-12-31

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Minced Iliac Crest autograft in osteotomysite

Group Type: EXPERIMENTAL

bonesubstitution (Calcibon, Iliac Crest Bonegraft, control)

Intervention Type: PROCEDURE

Osteotomysite are filled with Calcibon (an injectable calcium phosphate cement) or Minced Iliac Crest Bonegraft og local graft as control

2

Injectable calcium phosphate cement in osteotomysite

Group Type: EXPERIMENTAL

bonesubstitution (Calcibon, Iliac Crest Bonegraft, control)

Intervention Type: PROCEDURE

Osteotomysite are filled with Calcibon (an injectable calcium phosphate cement) or Minced Iliac Crest Bonegraft og local graft as control

3

Local autograft in the osteotomysite serves as control

Group Type: ACTIVE_COMPARATOR

bonesubstitution (Calcibon, Iliac Crest Bonegraft, control)

Intervention Type: PROCEDURE

Osteotomysite are filled with Calcibon (an injectable calcium phosphate cement) or Minced Iliac Crest Bonegraft og local graft as control

Interventions

bonesubstitution (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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Company CCBR A/S

UNKNOWN

Sponsor Role: collaborator

Northern Orthopaedic Division, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Lind-Hansen, MD

Role: PRINCIPAL_INVESTIGATOR

Northern Orthopaedic Division, Denmark

Locations

Northern Orthopaedic Division, Klinik Farsoe, Aalborg University Hospital

Farsø, Northern Jutland, Denmark

Countries

Denmark

Other Identifiers

ON-01-004-ML

Identifier Type: -

Identifier Source: org_study_id