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

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ClinicalTrials.gov Identifier: NCT01727739
Recruitment Status : Active, not recruiting
First Posted : November 16, 2012
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
ACL Device: Linvatec PLLA+TCP Device: Linvatec PLLA

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Tibial Tunnel Widening in ACL Reconstruction-Comparing Two Bioscrews: A Prospective Randomized Clinical Trial
Study Start Date : November 2012
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Radiographs [ Time Frame: 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 Outcome Measures :
  1. ACL Quality of Life Scores [ Time Frame: 12 months post op ]
    Completed at 3-, 6- and 12-months post operatively for subjective outcome measure.


Other Outcome Measures:
  1. IKDC Assessment [ Time Frame: 12 months post op ]
    Range of motion assessment at 3-,6-and 12-months post operatively.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727739


Locations
Canada, Manitoba
Pan Am Clinic
Winnipeg, Manitoba, Canada, R3M 3E4
Sponsors and Collaborators
Panam Clinic
Investigators
Principal Investigator: Peter B MacDonald, MD FRCS(C) Pan Am Clinic
More Information

Responsible Party: Peter MacDonald, Research Associate, Panam Clinic
ClinicalTrials.gov Identifier: NCT01727739     History of Changes
Other Study ID Numbers: B2012:059
First Posted: November 16, 2012    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

Keywords provided by Peter MacDonald, Panam Clinic:
Tibial tunnel widening
Interference screws