ACL Clinical Trial
Official title:
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.
n/a
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