Clinical trial NCT02845141: Synthetic Bone Graft Substitute vs. Autologous Spongiosa in Revision Anterior Cruciate Ligament Reconstruction
Official title: Synthetic Bone Graft Substitute (Actifuse) vs. Autologous Spongiosa for Tunnel Enlargement in Revision Anterior Cruciate Ligament Reconstruction - a Histological and Radiological Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Keywords: ACL
Revision surgery
tunnel enlargement
bone substitute material
bone graft
Lead sponsor: Berufsgenossenschaftliche Unfallklinik Ludwigshafen
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* Patients in need of revision anterior cruciate ligament reconstruction

Exclusion Criteria:

* Infection, wound healing complications

Primary outcomes:
measure: histological assessment of bony consolidation
timeFrame: 6 months postop
Secondary outcomes:
measure: Tegner Activity Score
timeFrame: 3, 6 and 12 Months
measure: IKDC Score
timeFrame: 3, 6 and 12 Months
measure: stability measurement using KT1000
timeFrame: 3, 6 and 12 Months
measure: SF36-Score
timeFrame: 3, 6 and 12 Months
Other outcomes:
Locations:
city: Ludwigshafen
country: Germany
facility: BG Unfallklinik
Study officials:
affiliation: BG Unfallklinik Ludwigshafen
name: Jan von Recum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BG Unfallklinik Ludwigshafen
name: Marc Schnetzke, MD
role: STUDY_CHAIR
References: