Safety and Efficacy Study of the Z-Lig Medical Device Compared to Allograft

A Prospective, Randomized, Double-Blind, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of the Z-Lig Medical Device Compared to Allograft for the Reconstruction of Ruptured Anterior Cruciate Ligaments

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01245400

Acronym

Z-Lig

Enrollment

Registered

2010-11-22

Start date

2010-11-30

Completion date

2017-04-30

Last updated

2014-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ruptured Anterior Cruciate Ligaments

Keywords

Z-Lig, allograft, ACL, Anterior Cruciate Ligament, ACLR, Anterior Cruciate Ligament Reconstruction, EU, European Union, S. Africa, Reconstruction of ruptured anterior cruciate ligaments

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.

Detailed description

Current techniques to reconstruct ruptured ACLs utilize either autologous tissue or allograft (cadaver) tissue. Both treatments have well-documented shortcomings (i.e., autologous tissue exposes patients to increased morbidity and allograft tissue use is limited by global availability and quality). There are currently no effective artificial materials or xenograft tissue substitutes widely available. The purpose of this multicenter clinical trial is to evaluate the safety and efficacy of the Z-Lig in Subjects who require reconstruction of primary ruptured anterior cruciate ligaments and compare those results to allograft.

Interventions

DEVICEZ-Lig

ACL replacement

DEVICEallograft

ACL replacement

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

Contact Sponsor

Design outcomes

Primary

Measure	Time frame	Description
KT-1000	baseline, 3,6, 12 & 24 monhts	Contact Sponsor

Countries

Belgium, Denmark, Italy, Netherlands, South Africa, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026