Tibial Tunnel Widening in Anterior Cruciate Ligament (ACL) Reconstruction-Comparing Two Bioscrews
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Purpose
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 2 weeks, and 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 | Intervention |
|---|---|
|
ACL |
Device: Linvatec PLLA+TCP Device: Linvatec PLLA |
| Study Type: | Interventional |
| 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 |
- Change in tibial tunnel diameter based on radiographs [ Time Frame: 2 weeks, 6 weeks and 12 months post op ] [ Designated as safety issue: No ]At 2 weeks, and 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).
- Evidence of lysis in tunnel (based on radiograph) [ Time Frame: 2-weeks, 6 months, 12 months ] [ Designated as safety issue: No ]Evidence of lysis in the tunnel
- Changes in morphological features of tunnel over time [ Time Frame: 2-weeks, 6 months, 12 months post-op ] [ Designated as safety issue: No ]Radiographs will be reviewed and changes in features will be documented using standardized list of descriptors
| Estimated Enrollment: | 80 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts 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)
Contacts and Locations| Canada, Manitoba | |
| Pan Am Clinic | Recruiting |
| Winnipeg, Manitoba, Canada, R3M 3E4 | |
| Contact: Sheila McRae, MSc 204-925-7469 smcrae@panamclinic.com | |
| Contact: Alexandra Legary, BSc 204-925-1558 alegary@panamclinic.com | |
| 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 |
More Information
No publications provided
| Responsible Party: | Peter MacDonald, Research Associate, Panam Clinic |
| ClinicalTrials.gov Identifier: | NCT01727739 History of Changes |
| Other Study ID Numbers: | B2012:059 |
| Study First Received: | November 7, 2012 |
| Last Updated: | November 12, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Panam Clinic:
|
Tibial tunnel widening Interference screws |
ClinicalTrials.gov processed this record on May 19, 2013