Clinical trial NCT01727739: Tibial Tunnel Widening in Anterior Cruciate Ligament (ACL) Reconstruction-Comparing Two Bioscrews
Official title: Tibial Tunnel Widening in ACL Reconstruction-Comparing Two Bioscrews: A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACL
Keywords: Tibial tunnel widening
Interference screws
Lead sponsor: Panam Clinic
Sponsor class: OTHER
First posted: 2012-11-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Radiographs
timeFrame: 12 months post op
Secondary outcomes:
measure: ACL Quality of Life Scores
timeFrame: 12 months post op
Other outcomes:
measure: IKDC Assessment
timeFrame: 12 months post op
Locations:
city: Winnipeg
country: Canada
facility: Pan Am Clinic
state: Manitoba
Study officials:
affiliation: Pan Am Clinic
name: Peter B MacDonald, MD FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References: