Synthetic Bone Graft Substitute vs. Autologous Spongiosa in Revision Anterior Cruciate Ligament Reconstruction
NCT ID: NCT02845141
Last Updated: 2018-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2013-03-31
2017-07-31
Brief Summary
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Clinical correlation with the histological and radiological results using the SF36 questionnaire.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Actifuse
Actifuse to fill bone tunnel
Actifuse
bone tunnel filled with Actifuse
bone graft
bone graft to fill bone tunnel
bone graft
bone graft to fill bone tunnel
Interventions
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Actifuse
bone tunnel filled with Actifuse
bone graft
bone graft to fill bone tunnel
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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Berufsgenossenschaftliche Unfallklinik Ludwigshafen
OTHER
Responsible Party
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Jan von Recum
Dr. med.
Principal Investigators
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Jan von Recum, MD
Role: PRINCIPAL_INVESTIGATOR
BG Unfallklinik Ludwigshafen
Marc Schnetzke, MD
Role: STUDY_CHAIR
BG Unfallklinik Ludwigshafen
Locations
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BG Unfallklinik
Ludwigshafen, , Germany
Countries
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Other Identifiers
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Baxter_Actifuse_001
Identifier Type: -
Identifier Source: org_study_id
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