Synthetic Bone Graft Substitute vs. Autologous Spongiosa in Revision Anterior Cruciate Ligament Reconstruction

Study Overview
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Brief Summary
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The overall objective is the histological and radiological assessment of bony consolidation of the tibial/femoral tunnel using either bone graft substitute (Actifuse) or autologous spongiosa in patients undergoing revision anterior cruciate ligament reconstruction. Clinical correlation with the histological and radiological results using the SF36 questionnaire.

Detailed Description
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* Study design: Monocentric, prospective, randomised study. Patients who need revision anterior cruciate ligament reconstruction and show a tunnel enlargement of >10mm will have a first operation filling the tibial/femoral tunnel either with bone graft substitute (Actifuse) or autologous spongiosa. 5 - 6 months after this first operation a CT will be performed to assess the bony consolidation of the former tibial/femoral tunnel. An MRI will be performed to assess vitality of the bone substitute. An osseous biopsy will be taken from the tibial/femoral tunnel at the revision anterior cruciate ligament reconstruction approximately 6 months after bone grafting. Clinical evaluation will be performed 6 weeks, 3 months and 6 months postoperative. At 6 months postoperative additional radiological evaluation and clinical assessment using the SF36 questionnaire will be performed. Treatment: Either autologous spongiosa or Actifuse (MIS applicator) will be administered by the investigator as a bone graft substitute for tunnel enlargement in patients undergoing revision anterior cruciate ligament reconstruction. Duration of Participation: The participation of each subject will be approximately 12 months. Each subject will undergo revision anterior cruciate ligament reconstruction approximately 6 months after bone grafting. A biopsy will be taken at this operation. A clinical and radiological follow up is planned for further 6 months. * Subjects: Male and female patients ≥ 18 years. Approximately 40 patients who undergo revision anterior cruciate ligament reconstruction will be included in the study. Inclusion criteria: Patients in need of revision anterior cruciate ligament reconstruction Exclusion criteria: Infection, wound healing complications

Official Title
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Synthetic Bone Graft Substitute (Actifuse) vs. Autologous Spongiosa for Tunnel Enlargement in Revision Anterior Cruciate Ligament Reconstruction - a Histological and Radiological Assessment

Conditions
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Anterior Cruciate Ligament Injury

Intervention / Treatment
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* Procedure: Actifuse
* Procedure: bone graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in need of revision anterior cruciate ligament reconstruction Exclusion Criteria: Infection, wound healing complications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Actifuse<br>Actifuse to fill bone tunnel | Procedure: Actifuse<br>* bone tunnel filled with Actifuse<br>* Other names: Baxter Actifuse MIS;|
| Active Comparator: bone graft<br>bone graft to fill bone tunnel | Procedure: bone graft<br>* bone graft to fill bone tunnel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histological assessment of bony consolidation | histological probes during second intervention to measure bony ingrowth into bone substitute material | 6 months postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tegner Activity Score | functional score | 3, 6 and 12 Months | 
| IKDC Score | functional score | 3, 6 and 12 Months | 
| stability measurement using KT1000 | functional score | 3, 6 and 12 Months | 
| SF36-Score | health score | 3, 6 and 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL, Revision surgery, tunnel enlargement, bone substitute material, bone graft