This trial is active, not recruiting.

Condition acl
Treatments linvatec plla+tcp, linvatec plla
Sponsor Panam Clinic
Start date November 2012
End date November 2017
Trial size 80 participants
Trial identifier NCT01727739, B2012:059


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
(Active Comparator)
poly-L-lactic acid bioscrew
linvatec plla
Linvatec PLLA tibial interference screw fixation will be used in ACL reconstruction.
(Active Comparator)
poly-l-lactic acid with beta tricalcium phosphate bioscrew
linvatec plla+tcp
Linvatec PLLA+TCP tibial interference screw fixation will be used in ACL reconstruction.

Primary Outcomes

time frame: 12 months post op

Secondary Outcomes

ACL Quality of Life Scores
time frame: 12 months post op

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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)

Additional Information

Official title Tibial Tunnel Widening in ACL Reconstruction-Comparing Two Bioscrews: A Prospective Randomized Clinical Trial
Principal investigator Peter B MacDonald, MD FRCS(C)
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Panam Clinic.