NCT01245400

Brief Summary

The purpose of this Trial is to demonstrate the safety and efficacy of the Investigational Device for the treatment of ruptured Anterior Cruciate Ligament (ACL) of the knee compared to Allograft.

Trial Health

50
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable

Geographic Reach
6 countries

6 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 22, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

March 13, 2014

Status Verified

March 1, 2014

Enrollment Period

3.4 years

First QC Date

November 1, 2010

Last Update Submit

March 11, 2014

Conditions

Ruptured Anterior Cruciate Ligaments

Keywords

Z-LigallograftACLAnterior Cruciate LigamentACLRAnterior Cruciate Ligament ReconstructionEUEuropean UnionS. AfricaReconstruction of ruptured anterior cruciate ligaments

Outcome Measures

Primary Outcomes (1)

  • KT-1000

    Contact Sponsor

    baseline, 3,6, 12 & 24 monhts

Study Arms (2)

Z-Lig

EXPERIMENTAL

Z-Lig Anterior Cruciate Ligament Reconstruction (ACLR) graft implantation performed under anesthesia during an arthroscopic procedure.

Device: Z-Lig

Allograft

ACTIVE COMPARATOR

Allograft bone/tendon graft implantation performed under anesthesia during an arthroscopic procedure.

Device: allograft

Interventions

Z-LigDEVICE

ACL replacement

Z-Lig
allograftDEVICE

ACL replacement

Allograft

Eligibility Criteria

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Contact Sponsor, Belgium

Location

Unknown Facility

Contact Sponsor, Denmark

Location

Unknown Facility

Bologna, Italy

Location

Unknown Facility

Contact Sponsor, Netherlands

Location

Unknown Facility

Contact Sponsor, South Africa

Location

Unknown Facility

Contact Sponsor, Spain

Location

Related Links

MeSH Terms

Interventions

Transplantation, Homologous

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2010

First Posted

November 22, 2010

Study Start

November 1, 2010

Primary Completion

April 1, 2014

Study Completion

April 1, 2017

Last Updated

March 13, 2014

Record last verified: 2014-03

Locations

ZA(1)BE(1)NL(1)ES(1)IT(1)DK(1)