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

Tibial Tunnel Widening in ACL Reconstruction-Comparing Two Bioscrews: A Prospective Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: ACL
• Intervention / Treatment: Device: Linvatec PLLA; Device: Linvatec PLLA+TCP

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3E4
      • Pan Am Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PLLA bioscrew; poly-L-lactic acid bioscrew	Device: Linvatec PLLA; Linvatec PLLA tibial interference screw fixation will be used in ACL reconstruction.
Active Comparator: PLLA+TCP bioscrew; poly-l-lactic acid with beta tricalcium phosphate bioscrew	Device: Linvatec PLLA+TCP; Linvatec PLLA+TCP tibial interference screw fixation will be used in ACL reconstruction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographs	At 3-, 6- and 12-months post-operatively, subjects will undergo radiographic examination of their affected knee (standardized AP and lateral views) for analysis of tibial tunnel parameters. Radiographic analysis will be conducted by a single orthopaedic surgeon/fellow/resident blinded to subject group and clinical examination results. Parameters to be recorded and analyzed according to a standardized method: tibial tunnel diameter (max/min). We will also look for: Evidence of lysis in the tunnel and changes in morphological features of tunnel over time	12 months post op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACL Quality of Life Scores	Completed at 3-, 6- and 12-months post operatively for subjective outcome measure.	12 months post op

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
IKDC Assessment	Range of motion assessment at 3-,6-and 12-months post operatively.	12 months post op

Collaborators and Investigators

• Sponsor: Panam Clinic
• Investigators: Principal Investigator: Peter B MacDonald, MD FRCS(C), Pan Am Clinic

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: November 7, 2012
• First Submitted That Met QC Criteria: November 12, 2012
• First Posted (Estimate): November 16, 2012

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 15, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Tibial tunnel widening; Interference screws
• Other Study ID Numbers: B2012:059

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No