Evaluation of Tibial and Femoral Tunnel Position After Ar... | NCT01267435

Studies
Evaluation of Tibial and Femoral Tunnel Position After Arthroscopic Reconstruction of the Anterior Cruciate Ligament

NCT01267435

Sponsor

Isfahan University of Medical Sciences

Status

Completed

Last Update Posted

Dec 28, 2010Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Anterior Cruciate Ligament Rupture

Interventions

Anterior cruciate ligament reconstruction

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

Status Module

Record Verification Date

Oct 2008

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

Oct 2008

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Dec 27, 2010

First Submission Date that Met QC Criteria

Dec 27, 2010

First Posted Date

Dec 28, 2010Estimated

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

Dec 27, 2010

Last Update Posted Date

Dec 28, 2010Estimated

Name	Class
Shahid Beheshti University of Medical Sciences	OTHER

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 evaluate the accuracy of tunnel positions in anterior cruciate ligament reconstruction

Detailed Description

The tunnel placement in ACL reconstruction is the most important predictor of clinical outcome and there is a high rate of inaccurate tunnel placements, even when performed by experienced surgeons.Tibial and femoral tunnel positions are one of the major concerns in anterior cruciate ligament reconstruction which have a great impact on the final surgical results

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
determining correct tunnel positions	Other		Procedure: Anterior cruciate ligament reconstruction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anterior cruciate ligament reconstruction	Procedure	reconstruct the anterior cruciate ligament rupturing	determining correct tunnel positions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of correct femoral tunnel position	we evalauted femoral tunnel positions	5 min after operation

Secondary Outcomes

Measure	Description	Time Frame
number of correct Tibial tunnel position	we evalauted tibial tunnel position	5 min after operation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

anterior cruciate ligament rupturing

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

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
hamidreza shemshaki, MD	research comittee	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akhtar university hospital		Tehran	Tehran Province		Iran

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059549	Anterior Cruciate Ligament Reconstruction

Ancestor Terms

ID	Term
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative
D019651	Plastic Surgery Procedures

Browse Leaves

Not provided

Browse Branches

Not provided