Tibial Tunnel Widening in Anterior Cruciate Ligament (ACL) Reconstruction-Comparing Two Bioscrews
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|ClinicalTrials.gov Identifier: NCT01727739|
Recruitment Status : Active, not recruiting
First Posted : November 16, 2012
Last Update Posted : September 19, 2017
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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Tibial Tunnel Widening in ACL Reconstruction-Comparing Two Bioscrews: A Prospective Randomized Clinical Trial|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||December 2018|
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.
- Radiographs [ Time Frame: 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
- ACL Quality of Life Scores [ Time Frame: 12 months post op ]Completed at 3-, 6- and 12-months post operatively for subjective outcome measure.
- IKDC Assessment [ Time Frame: 12 months post op ]Range of motion assessment at 3-,6-and 12-months post operatively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727739
|Pan Am Clinic|
|Winnipeg, Manitoba, Canada, R3M 3E4|
|Principal Investigator:||Peter B MacDonald, MD FRCS(C)||Pan Am Clinic|