The Effect of Knee Flexion Angle for Graft Fixation Durin... | NCT02111759

Studies
The Effect of Knee Flexion Angle for Graft Fixation During Single-Bundle Anterior Cruciate Ligament Reconstruction

NCT02111759

Sponsor

University of Toronto Orthopaedic Sports Medicine

Status

Unknown status

Last Update Posted

Nov 10, 2016Estimated

Enrollment

204Actual

Phase

Not Applicable

Conditions

Anterior Cruciate Ligament Injury

Interventions

knee flexion angle 1
knee flexion angle 2

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

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Feb 2018Estimated

Completion Date

Feb 2018Estimated

First Submitted Date

Mar 27, 2014

First Submission Date that Met QC Criteria

Apr 8, 2014

First Posted Date

Apr 11, 2014Estimated

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

Nov 9, 2016

Last Update Posted Date

Nov 10, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jaskarndip Chahal, Principal Investigator, University of Toronto Orthopaedic Sports MedicinePrincipal Investigator

Lead Sponsor

University of Toronto Orthopaedic Sports MedicineOTHER

Collaborators

Name	Class
Arthroscopy Association of North America	OTHER

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

The purpose of this study is to conduct a randomized controlled trial to determine if the knee flexion angle (KFA) during anterior cruciate ligament reconstruction (ACLR) graft fixation has an effect on postoperative outcomes. The specific research questions are: what is the effect of the KFA on 1) patient-reported outcomes; 2) postoperative extension loss; 3) antero-posterior (AP) knee stability; 4) rate of re-operation.

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

204Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
knee flexion angle 2	Other	30 degrees of knee flexion during ACL graft fixation	Procedure: knee flexion angle 2
knee flexion angle 1	Other	0 degrees of knee flexion during ACL graft fixation	Procedure: knee flexion angle 1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
knee flexion angle 1	Procedure	0 degrees of knee flexion during ACL graft fixation	knee flexion angle 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS)		24 months postoperatively

Secondary Outcomes

Measure	Description	Time Frame
KOOS scores		3, 6, and 12 months
Marx Activity Score (MAS)		3, 6, 12, 24 months
the degree of extension loss in the affected knee (vs. contralateral knee)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female patients older than 16 years old with an isolated anterior cruciate ligament injury as diagnosed by clinical examination and MRI
No pre-existing arthritis as defined by the Kellgren-Lawrence radiographic rating system
Patients treated with an initial period of rehabilitation to eliminate swelling, optimize quadriceps strength and restore range of motion
surgical management with a transtibial or anteromedial portal single-bundle ACLR with bone patella tendon bone (BPTB) autograft by a fellowship-trained sports medicine surgeon.

Exclusion Criteria:

Acute ACL injuries that have not undergone an initial period of physical therapy in order to restore the aforementioned parameters
Associated grade III injury to the MCL (medial opening >10mm at 30 degrees of knee flexion or any medial opening in extension)
Presence of a PCL or posterolateral corner injury
Lack of informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jaskarndip Chahal, MD	University of Toronto Orthopaedic Sports Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women's College Hospital		Toronto	Ontario	M5S1B1	Canada

Condition Browse Module

MeSH Terms

ID	Term
D000070598	Anterior Cruciate Ligament Injuries

Ancestor Terms

ID	Term
D007718	Knee Injuries
D007869	Leg Injuries
D014947	Wounds and Injuries

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