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

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Injury
• Interventions: Procedure: bone graft; Procedure: Actifuse

• Registration Number: NCT02845141
• Lead Sponsor: Berufsgenossenschaftliche Unfallklinik Ludwigshafen

Brief Summary

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

\* 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

Study Timeline

• Study First Submitted: 2012-10-13
• Study Start: 2013-03
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-27
• Primary Completion: 2016-09
• Study Completion: 2017-07
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-18
• Last Update Posted: 2018-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients in need of revision anterior cruciate ligament reconstruction

Exclusion Criteria

• Infection, wound healing complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bone graft	bone graft	bone graft to fill bone tunnel
Actifuse	Actifuse	Actifuse to fill bone tunnel

Primary Outcome Measures

Name	Time	Method
histological assessment of bony consolidation	6 months postop	histological probes during second intervention to measure bony ingrowth into bone substitute material

Secondary Outcome Measures

Name	Time	Method
IKDC Score	3, 6 and 12 Months	functional score
stability measurement using KT1000	3, 6 and 12 Months	functional score
SF36-Score	3, 6 and 12 Months	health score
Tegner Activity Score	3, 6 and 12 Months	functional score

Trial Locations

Locations (1)

BG Unfallklinik; 🇩🇪 Ludwigshafen, Germany