NCT01727739

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 16, 2012

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

5.4 years

First QC Date

November 7, 2012

Last Update Submit

March 15, 2019

Conditions

ACL

Keywords

Tibial tunnel wideningInterference screws

Outcome Measures

Primary Outcomes (1)

  • Radiographs

    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

    12 months post op

Secondary Outcomes (1)

  • ACL Quality of Life Scores

    12 months post op

Other Outcomes (1)

  • IKDC Assessment

    12 months post op

Study Arms (2)

PLLA bioscrew

ACTIVE COMPARATOR

poly-L-lactic acid bioscrew

Device: Linvatec PLLA

PLLA+TCP bioscrew

ACTIVE COMPARATOR

poly-l-lactic acid with beta tricalcium phosphate bioscrew

Device: Linvatec PLLA+TCP

Interventions

Linvatec PLLA+TCPDEVICE

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

PLLA+TCP bioscrew
Linvatec PLLADEVICE

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

PLLA bioscrew

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Must have a unilateral ACL rupture
  • Patients must be between 18 and 45 years old

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

Location

Study Officials

  • Peter B MacDonald, MD FRCS(C)

    Pan Am Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

November 7, 2012

First Posted

November 16, 2012

Study Start

November 1, 2012

Primary Completion

April 1, 2018

Study Completion

December 1, 2018

Last Updated

March 19, 2019

Record last verified: 2019-03

Locations

CA(1)