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

NCT00319280 | Completed Phase 4

• 1 other identifier: ON-01-004-ML
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

Osteoarthritis, Knee; Osteotomy; Healing; Roentgen Stereometric Analysis

Outcome Measures

Primary Outcomes (1)

• Migration in mm measured with RSA (Roentgen Stereometric Analysis)

  postoperative, at 3 month, 1 and 2 years

Secondary Outcomes (6)

• Hip-Knee-Ankle axis

  3 month, 1 and 2 years.

• 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

• Markers of bone synthesis and degradation

  preoperative, at 6 weeks, 3 month, 1 and 2 years postoperative

• Clinical scores: KOOS, Lysholm, SF12, Knee Score

  Preoperatively, Postoperatively, 6 weeks, 3 months, 1 year and 2 years

Study Arms (3)

1

EXPERIMENTAL

Minced Iliac Crest autograft in osteotomysite

Procedure: bonesubstitution (Calcibon, Iliac Crest Bonegraft, control)

2

EXPERIMENTAL

Injectable calcium phosphate cement in osteotomysite

Procedure: bonesubstitution (Calcibon, Iliac Crest Bonegraft, control)

3

ACTIVE COMPARATOR

Local autograft in the osteotomysite serves as control

Procedure: bonesubstitution (Calcibon, Iliac Crest Bonegraft, control)

Interventions

bonesubstitution (Calcibon, Iliac Crest Bonegraft, control) PROCEDURE

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

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern Orthopaedic Division, Denmark: lead
• Company CCBR A/S: collaborator

Study Sites (1)

Northern Orthopaedic Division, Klinik Farsoe, Aalborg University Hospital

Farsø, Northern Jutland, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Thomas Lind-Hansen, MD

  Northern Orthopaedic Division, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2006
• First Posted: April 27, 2006
• Study Start: December 1, 2004
• Primary Completion: June 1, 2006
• Study Completion: December 1, 2008
• Last Updated: March 31, 2014

Record last verified: 2014-03

Locations

DK (1)