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NCT Number: NCT01727739

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

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.

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Key information

Conditions

ACL

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Linvatec PLLA+TCP

Device

Linvatec PLLA+TCP tibial interference screw fixation will be used in ACL reconstruction.

Linvatec PLLA

Device

Linvatec PLLA tibial interference screw fixation will be used in ACL reconstruction.

Primary outcomes

  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 outcomes

  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 outcomes

  1. IKDC Assessment

    Time frame: 12 months post op

    Range of motion assessment at 3-,6-and 12-months post operatively.

Sponsors and collaborators

Lead sponsor

Panam Clinic

Other

Registry information

Official study title

Tibial Tunnel Widening in ACL Reconstruction-Comparing Two Bioscrews: A Prospective Randomized Clinical Trial

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Nov 16, 2012
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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