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

NCT02845141 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-01-19

No results posted yet for this study

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.

Conditions

  • Anterior Cruciate Ligament Injury

Interventions

PROCEDURE

Actifuse

bone tunnel filled with Actifuse

PROCEDURE

bone graft

bone graft to fill bone tunnel

Sponsors & Collaborators

  • Berufsgenossenschaftliche Unfallklinik Ludwigshafen

    lead OTHER

Principal Investigators

  • Jan von Recum, MD · BG Unfallklinik Ludwigshafen

  • Marc Schnetzke, MD · BG Unfallklinik Ludwigshafen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2016-09-30
Completion
2017-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02845141 on ClinicalTrials.gov