Functional Outcome Anterior Cruciate Ligament Reconstruction | NCT01693757

Studies
Functional Outcome Anterior Cruciate Ligament Reconstruction

NCT01693757

Sponsor

University of Social Welfare and Rehabilitation Science

Status

Completed

Last Update Posted

Sep 26, 2012Estimated

Enrollment

63Actual

Phase

Not provided

Conditions

Complications of Surgical Procedures or Medical Care

Interventions

Not provided

Countries

Iran

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

ID	Type	Description	Link
USWR	Other Identifier	USWR

Status Module

Record Verification Date

Sep 2012

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

Jan 2010

Primary Completion Date

Jan 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

May 25, 2012

First Submission Date that Met QC Criteria

Sep 24, 2012

First Posted Date

Sep 26, 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

Sep 24, 2012

Last Update Posted Date

Sep 26, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Farshid Mohammadi, Director, University of Social Welfare and Rehabilitation SciencePrincipal Investigator

Lead Sponsor

University of Social Welfare and Rehabilitation ScienceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 compare hop performance and jump landing strategy in soccer players with higher level sports activities after ACLR using either BPTB or STG and controls.

Detailed Description

The choice of graft for anterior cruciate ligament reconstruction (ACLR) remains controversial. Despite the need for outcome studies comparing bone-patellar tendon-bone (BPTB) with semitendinosus and gracilis tendon (STG), few studies have evaluated functional outcomes. The objective of the current study was to compare hop performance and jump landing strategy in soccer players with higher level sports activities after ACLR using either BPTB or STG and controls.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BPTB group		Bone-patellar tendon-bone
STG group		Semitendinosus and gracilis tendon
Control		Healthy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hop values for the both legs in Single, 6-m, Cross-over and Triple hops		Patients were followed up to 8 months post-surgery

Secondary Outcomes

Measure	Description	Time Frame
Landing and Take-off Ground Reaction Forces		Patients were followed up to 8 months post-surgery
Strength of Quadriceps and Hamstrings		Patients were followed up to 8 months post-surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ACLR and controls.

Exclusion Criteria:

Musculoskeletal injuries

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

The patients with ACL deficiency were invited to participate in a randomized trial comparing ACLR with either a BPTB or STG graft.

Sampling Method

Probability Sample