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

Osteoarthritis, Knee Clinical Trial

Official title:

Proximal Tibial Open Wedge Osteotomy. Stability and Healing Evaluated in a Clinical Prospective, Randomized Trial Using RSA.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00319280
• Other study ID #: ON-01-004-ML
• Status: Completed
• Phase: Phase 4
• First received: April 27, 2006
• Last updated: March 28, 2014
• Start date: December 2004
• Est. completion date: December 2008

Study information

• Verified date: March 2014
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2008
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Denmark	Northern Orthopaedic Division, Klinik Farsoe, Aalborg University Hospital	Farsoe	Northern Jutland

Sponsors (2)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark	Company CCBR A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migration in mm measured with RSA (Roentgen Stereometric Analysis)		postoperative, at 3 month, 1 and 2 years	No
Secondary	Hip-Knee-Ankle axis		3 month, 1 and 2 years.	No
Secondary	MR of the knee		4 weeks preoperative, preoperative, at 1 and 2 years postoperative.	No
Secondary	Markers of chondral degradation		preoperative, at 6 weeks, 3 month, 1 and 2 years postoperative	No
Secondary	Markers of bone synthesis and degradation		preoperative, at 6 weeks, 3 month, 1 and 2 years postoperative	No
Secondary	Clinical scores: KOOS, Lysholm, SF12, Knee Score		Preoperatively, Postoperatively, 6 weeks, 3 months, 1 year and 2 years	No
Secondary	Histomorphometric evaluation of bone healing and osseous integration of cement		1 year	No