Tibial Tunnel Widening in Anterior Cruciate Ligament (ACL) Reconstruction-Comparing Two Bioscrews
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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Tibial Tunnel Widening in ACL Reconstruction-Comparing Two Bioscrews: A Prospective Randomized Clinical Trial|
- Radiographs [ Time Frame: 12 months post op ] [ Designated as safety issue: No ]
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
- ACL Quality of Life Scores [ Time Frame: 12 months post op ] [ Designated as safety issue: No ]Completed at 3-, 6- and 12-months post operatively for subjective outcome measure.
- IKDC Assessment [ Time Frame: 12 months post op ] [ Designated as safety issue: Yes ]Range of motion assessment at 3-,6-and 12-months post operatively.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727739
|Pan Am Clinic||Recruiting|
|Winnipeg, Manitoba, Canada, R3M 3E4|
|Contact: Sheila McRae, MSc 204-925-7469 email@example.com|
|Contact: Alexandra Legary, BSc 204-925-1558 firstname.lastname@example.org|
|Principal Investigator: Peter B MacDonald, MD FRCS(C)|
|Sub-Investigator: David Simon, MD FRCS(C)|
|Sub-Investigator: Jeff Leiter, PhD|
|Sub-Investigator: Sheila McRae, MSc|
|Principal Investigator:||Peter B MacDonald, MD FRCS(C)||Pan Am Clinic|