ACL
Conditions
Keywords
Tibial tunnel widening, Interference screws
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.
Interventions
DEVICELinvatec PLLA+TCP
Linvatec PLLA+TCP tibial interference screw fixation will be used in ACL reconstruction.
DEVICELinvatec PLLA
Linvatec PLLA tibial interference screw fixation will be used in ACL reconstruction.
Sponsors
Panam Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| ACL Quality of Life Scores | 12 months post op | Completed at 3-, 6- and 12-months post operatively for subjective outcome measure. |
Other
| Measure | Time frame | Description |
|---|---|---|
| IKDC Assessment | 12 months post op | Range of motion assessment at 3-,6-and 12-months post operatively. |
Countries
Canada
Outcome results
None listed