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

This study has been completed.
Sponsor:
Collaborator:
Company CCBR A/S
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT00319280
First received: April 27, 2006
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Knee
Procedure: bonesubstitution (Calcibon, Iliac Crest Bonegraft, control)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Proximal Tibial Open Wedge Osteotomy. Stability and Healing Evaluated in a Clinical Prospective, Randomized Trial Using RSA.

Resource links provided by NLM:


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:
  • Hip-Knee-Ankle axis [ Time Frame: 3 month, 1 and 2 years. ] [ Designated as safety issue: No ]
  • MR of the knee [ Time Frame: 4 weeks preoperative, preoperative, at 1 and 2 years postoperative. ] [ Designated as safety issue: No ]
  • Markers of chondral degradation [ Time Frame: preoperative, at 6 weeks, 3 month, 1 and 2 years postoperative ] [ Designated as safety issue: No ]
  • Markers of bone synthesis and degradation [ Time Frame: preoperative, at 6 weeks, 3 month, 1 and 2 years postoperative ] [ Designated as safety issue: No ]
  • Clinical scores: KOOS, Lysholm, SF12, Knee Score [ Time Frame: Preoperatively, Postoperatively, 6 weeks, 3 months, 1 year and 2 years ] [ Designated as safety issue: No ]
  • Histomorphometric evaluation of bone healing and osseous integration of cement [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: December 2004
Study Completion Date: December 2008
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Minced Iliac Crest autograft in osteotomysite
Procedure: 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
Experimental: 2
Injectable calcium phosphate cement in osteotomysite
Procedure: 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
Active Comparator: 3
Local autograft in the osteotomysite serves as control
Procedure: 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319280

Locations
Denmark
Northern Orthopaedic Division, Klinik Farsoe, Aalborg University Hospital
Farsoe, Northern Jutland, Denmark
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Company CCBR A/S
Investigators
Principal Investigator: Thomas Lind-Hansen, MD Northern Orthopaedic Division, Denmark
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT00319280     History of Changes
Other Study ID Numbers: ON-01-004-ML
Study First Received: April 27, 2006
Last Updated: March 28, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Northern Orthopaedic Division, Denmark:
Osteoarthritis, Knee
Osteotomy
Healing
Roentgen Stereometric Analysis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 14, 2014