Tibial Tunnel Widening in Anterior Cruciate Ligament (ACL) Reconstruction-Comparing Two Bioscrews

NCT ID: NCT01727739

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2018-12-31

Brief Summary

Widening of the single tibial tunnel following ACL surgery with quadrupled hamstrings autograft may contribute to failure of the graft and/or present technical challenges secondary to bone loss in a revision setting (Getelman, 1999). As such, efforts should be made to minimize the incidence and magnitude of tibial tunnel widening without sacrificing the biomechanical properties of the graft construct. The purpose of this investigation is to examine the tibial tunnel widening relationship between bioabsorbable interference screws composed of poly-L-lactic acid (PLLA) alone and composite bioabsorbable interference screws composed of poly-L-lactic acid embedded with beta tricalcium phosphate (PLLA+TCP) utilized as tibial fixation devices.

Specifically the study has the following objectives: 1) To quantify the extent of tibial tunnel enlargement at 3-, 6- and 12-months post ACL reconstruction with autogenous quadrupled hamstring graft; 2) To determine if the incorporation of beta tricalcium phosphate to the bioabsorbable interference screw alters the observed magnitude of tunnel widening; 3) To hypothesize mechanisms for any observed differences between tibial fixation devices; and 4) To correlate tibial tunnel widening with clinical outcome status. It is hypothesized that the PLLA+TCP bioabsorbable interference screw will not be associated with a reduction in tibial tunnel widening around the implant but rather between the implant and articular surface, compared to the PLLA alone screw. It is also hypothesized that there will be no effect of observed tunnel widening on clinical outcomes or graft failure rates.

Conditions

ACL

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PLLA bioscrew

poly-L-lactic acid bioscrew

Group Type: ACTIVE_COMPARATOR

Linvatec PLLA

Intervention Type: DEVICE

Linvatec PLLA tibial interference screw fixation will be used in ACL reconstruction.

PLLA+TCP bioscrew

poly-l-lactic acid with beta tricalcium phosphate bioscrew

Group Type: ACTIVE_COMPARATOR

Linvatec PLLA+TCP

Intervention Type: DEVICE

Linvatec PLLA+TCP tibial interference screw fixation will be used in ACL reconstruction.

Interventions

Linvatec PLLA+TCP

Linvatec PLLA+TCP tibial interference screw fixation will be used in ACL reconstruction.

Intervention Type: DEVICE

Linvatec PLLA

Linvatec PLLA tibial interference screw fixation will be used in ACL reconstruction.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Must have a unilateral ACL rupture
• Patients must be between 18 and 45 years old

Exclusion Criteria

• Concomitant medial collateral, lateral collateral, or posterior collateral ligament tears
• Severe chondromalacia or severe meniscal tear
• Previous history of ipsilateral knee joint pathology, surgery, or trauma to that knee
• Unwillingness to be followed for 12 months post-operatively
• History of arthritis (osteoarthritis or rheumatoid)
• Pregnancy
• Psychiatric illness that precludes informed consent
• Unable to speak or read English/French
• Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Panam Clinic

OTHER

Sponsor Role: lead

Responsible Party

Peter MacDonald

Research Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter B MacDonald, MD FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

Pan Am Clinic

Locations

Pan Am Clinic

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

B2012:059

Identifier Type: -

Identifier Source: org_study_id