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

Sponsor

Panam Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01727739

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ACL	Device: Linvatec PLLA+TCP Device: Linvatec PLLA	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Apr 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Radiographs [12 months post op]
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

Secondary Outcome Measures

ACL Quality of Life Scores [12 months post op]
Completed at 3-, 6- and 12-months post operatively for subjective outcome measure.

Other Outcome Measures

IKDC Assessment [12 months post op]
Range of motion assessment at 3-,6-and 12-months post operatively.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pan Am Clinic	Winnipeg	Manitoba	Canada	R3M 3E4

Sponsors and Collaborators

Panam Clinic

Investigators

Principal Investigator: Peter B MacDonald, MD FRCS(C), Pan Am Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peter MacDonald, Research Associate, Panam Clinic

ClinicalTrials.gov Identifier:

NCT01727739

Other Study ID Numbers:

B2012:059

First Posted:

Nov 16, 2012

Last Update Posted:

Mar 19, 2019

Last Verified:

Mar 1, 2019

Keywords provided by Peter MacDonald, Research Associate, Panam Clinic

Tibial tunnel widening

Interference screws

Study Results

No Results Posted as of Mar 19, 2019