Synthetic Bone Graft Substitute vs. Autologous Spongiosa... | NCT02845141

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

NCT02845141

Sponsor

Berufsgenossenschaftliche Unfallklinik Ludwigshafen

Status

Completed

Last Update Posted

Jan 19, 2018Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Anterior Cruciate Ligament Injury

Interventions

Actifuse
bone graft

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Sep 2016Actual

Completion Date

Jul 2017Actual

First Submitted Date

Oct 13, 2012

First Submission Date that Met QC Criteria

Jul 22, 2016

First Posted Date

Jul 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2018

Last Update Posted Date

Jan 19, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jan von Recum, Dr. med., Berufsgenossenschaftliche Unfallklinik LudwigshafenPrincipal Investigator

Lead Sponsor

Berufsgenossenschaftliche Unfallklinik LudwigshafenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Actifuse	Experimental	Actifuse to fill bone tunnel	Procedure: Actifuse
bone graft	Active Comparator	bone graft to fill bone tunnel	Procedure: bone graft

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Actifuse	Procedure	bone tunnel filled with Actifuse	Actifuse	Baxter Actifuse MIS

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Tegner Activity Score	functional score	3, 6 and 12 Months
IKDC Score	functional score	3, 6 and 12 Months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients in need of revision anterior cruciate ligament reconstruction

Exclusion Criteria:

Infection, wound healing complications

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jan von Recum, MD	BG Unfallklinik Ludwigshafen	Principal Investigator
Marc Schnetzke, MD	BG Unfallklinik Ludwigshafen	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BG Unfallklinik		Ludwigshafen		67071	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070598	Anterior Cruciate Ligament Injuries

Ancestor Terms

ID	Term
D007718	Knee Injuries
D007869	Leg Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C519529	actifuse synthetic bone graft
D016025	Bone Transplantation

Ancestor Terms

ID	Term
D016378	Tissue Transplantation
D064987	Cell- and Tissue-Based Therapy
D001691	Biological Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided