Tibial Tunnel Widening in Anterior Cruciate Ligament (ACL) Reconstruction-Comparing Two Bioscrews

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Panam Clinic
Sponsor:
Information provided by (Responsible Party):
Peter MacDonald, Panam Clinic
ClinicalTrials.gov Identifier:
NCT01727739
First received: November 7, 2012
Last updated: March 5, 2014
Last verified: March 2014
  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 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 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

Resource links provided by NLM:


Further study details as provided by Panam Clinic:

Primary Outcome Measures:
  • Radiographs [ Time Frame: 12 months post op ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • ACL Quality of Life Scores [ Time Frame: 12 months post op ] [ Designated as safety issue: No ]
    Completed at 3-, 6- and 12-months post operatively for subjective outcome measure.


Other Outcome Measures:
  • IKDC Assessment [ Time Frame: 12 months post op ] [ Designated as safety issue: Yes ]
    Range of motion assessment at 3-,6-and 12-months post operatively.


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
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727739

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         
Sponsors and Collaborators
Panam Clinic
Investigators
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: March 5, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Panam Clinic:
Tibial tunnel widening
Interference screws

ClinicalTrials.gov processed this record on October 19, 2014