Tibial Tunnel Widening in Anterior Cruciate Ligament (ACL... | NCT01727739

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

NCT01727739

Sponsor

Panam Clinic

Status

Completed

Last Update Posted

Mar 19, 2019Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Interventions

Linvatec PLLA+TCP
Linvatec PLLA

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Apr 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

Nov 7, 2012

First Submission Date that Met QC Criteria

Nov 12, 2012

First Posted Date

Nov 16, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2019

Last Update Posted Date

Mar 19, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter MacDonald, Research Associate, Panam ClinicPrincipal Investigator

Lead Sponsor

Panam ClinicOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Linvatec PLLA+TCP	Device	Linvatec PLLA+TCP tibial interference screw fixation will be used in ACL reconstruction.	PLLA+TCP bioscrew

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
ACL Quality of Life Scores	Completed at 3-, 6- and 12-months post operatively for subjective outcome measure.	12 months post op

Other Outcomes

Measure	Description	Time Frame
IKDC Assessment	Range of motion assessment at 3-,6-and 12-months post operatively.	12 months post op

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter B MacDonald, MD FRCS(C)	Pan Am Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pan Am Clinic		Winnipeg	Manitoba	R3M 3E4	Canada