An interventional study of Actifuse and bone graft in Anterior Cruciate Ligament Injury, sponsored by Berufsgenossenschaftliche Unfallklinik Ludwigshafen. Completed at 1 site in Germany. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-01-19.
Sponsored by Berufsgenossenschaftliche Unfallklinik Ludwigshafen · Not applicable, Interventional, and Treatment
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.
* 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.
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
512 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 164 are open to participants now.
This study's enrollment of 40 is below the median of 56 across 373 interventional studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →Berufsgenossenschaftliche Unfallklinik Ludwigshafen is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Actifuse to fill bone tunnel
Procedure: Actifuse
bone graft to fill bone tunnel
Procedure: bone graft
bone tunnel filled with Actifuse
Also known as: Baxter Actifuse MIS
bone graft to fill bone tunnel
histological assessment of bony consolidation
histological probes during second intervention to measure bony ingrowth into bone substitute material
Time frame: 6 months postop
Tegner Activity Score
functional score
Time frame: 3, 6 and 12 Months
IKDC Score
functional score
Time frame: 3, 6 and 12 Months
stability measurement using KT1000
functional score
Time frame: 3, 6 and 12 Months
SF36-Score
health score
Time frame: 3, 6 and 12 Months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Anterior Cruciate Ligament Injuries→
Berufsgenossenschaftliche Unfallklinik Ludwigshafen