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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Procedure: bonesubstitution (Calcibon, Iliac Crest Bonegraft, control)

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Northern Jutland
    • Farsoe, Northern Jutland, Denmark
      • Northern Orthopaedic Division, Klinik Farsoe, Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Migration in mm measured with RSA (Roentgen Stereometric Analysis)	postoperative, at 3 month, 1 and 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Histomorphometric evaluation of bone healing and osseous integration of cement	1 year

Collaborators and Investigators

• Sponsor: Northern Orthopaedic Division, Denmark
• Collaborators: Company CCBR A/S
• Investigators: Principal Investigator: Thomas Lind-Hansen, MD, Northern Orthopaedic Division, Denmark

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (ACTUAL): June 1, 2006
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: April 27, 2006
• First Submitted That Met QC Criteria: April 27, 2006
• First Posted (ESTIMATE): April 27, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): March 31, 2014
• Last Update Submitted That Met QC Criteria: March 28, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Healing; Osteoarthritis, Knee; Osteotomy; Roentgen Stereometric Analysis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: ON-01-004-ML