NCT02845141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
3.4 years until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

3.5 years

First QC Date

October 13, 2012

Last Update Submit

January 18, 2018

Conditions

Anterior Cruciate Ligament Injury

Keywords

ACLRevision surgerytunnel enlargementbone substitute materialbone graft

Outcome Measures

Primary Outcomes (1)

  • histological assessment of bony consolidation

    histological probes during second intervention to measure bony ingrowth into bone substitute material

    6 months postop

Secondary Outcomes (4)

  • Tegner Activity Score

    3, 6 and 12 Months

  • IKDC Score

    3, 6 and 12 Months

  • stability measurement using KT1000

    3, 6 and 12 Months

  • SF36-Score

    3, 6 and 12 Months

Study Arms (2)

Actifuse

EXPERIMENTAL

Actifuse to fill bone tunnel

Procedure: Actifuse

bone graft

ACTIVE COMPARATOR

bone graft to fill bone tunnel

Procedure: bone graft

Interventions

ActifusePROCEDURE

bone tunnel filled with Actifuse

Also known as: Baxter Actifuse MIS
Actifuse
bone graftPROCEDURE

bone graft to fill bone tunnel

bone graft

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients in need of revision anterior cruciate ligament reconstruction

You may not qualify if:

  • Infection, wound healing complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BG Unfallklinik

Ludwigshafen, 67071, Germany

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

actifuse synthetic bone graftBone Transplantation

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsOrthopedic ProceduresSurgical Procedures, OperativeTransplantation

Study Officials

  • Jan von Recum, MD

    BG Unfallklinik Ludwigshafen

    PRINCIPAL INVESTIGATOR

  • Marc Schnetzke, MD

    BG Unfallklinik Ludwigshafen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

October 13, 2012

First Posted

July 27, 2016

Study Start

March 1, 2013

Primary Completion

September 1, 2016

Study Completion

July 1, 2017

Last Updated

January 19, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)