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

January 18, 2018 updated by: Jan von Recum, Berufsgenossenschaftliche Unfallklinik Ludwigshafen

Synthetic Bone Graft Substitute (Actifuse) vs. Autologous Spongiosa for Tunnel Enlargement in Revision Anterior Cruciate Ligament Reconstruction - a Histological and Radiological Assessment

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ludwigshafen, Germany, 67071
        • BG Unfallklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients in need of revision anterior cruciate ligament reconstruction

Exclusion Criteria:

  • Infection, wound healing complications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Actifuse
Actifuse to fill bone tunnel
Procedure: Actifuse
bone tunnel filled with Actifuse
Other Names:
  • Baxter Actifuse MIS
ACTIVE_COMPARATOR: bone graft
bone graft to fill bone tunnel
Procedure: bone graft
bone graft to fill bone tunnel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
histological assessment of bony consolidation
Time Frame: 6 months postop
histological probes during second intervention to measure bony ingrowth into bone substitute material
6 months postop

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tegner Activity Score
Time Frame: 3, 6 and 12 Months
functional score
3, 6 and 12 Months
IKDC Score
Time Frame: 3, 6 and 12 Months
functional score
3, 6 and 12 Months
stability measurement using KT1000
Time Frame: 3, 6 and 12 Months
functional score
3, 6 and 12 Months
SF36-Score
Time Frame: 3, 6 and 12 Months
health score
3, 6 and 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Berufsgenossenschaftliche Unfallklinik Ludwigshafen

Investigators

  • Principal Investigator: Jan von Recum, MD, BG Unfallklinik Ludwigshafen
  • Study Chair: Marc Schnetzke, MD, BG Unfallklinik Ludwigshafen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

July 1, 2017

Study Registration Dates

First Submitted

October 13, 2012

First Submitted That Met QC Criteria

July 22, 2016

First Posted (ESTIMATE)

July 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 19, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Baxter_Actifuse_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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