Evaluation the Operative Procedure Among Patients That Su... | NCT01343875

Studies
Evaluation the Operative Procedure Among Patients That Suffer From Tear of the Distal Tendon of the Biceps

NCT01343875

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Dec 28, 2011Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Biceps Tendon Rupture

Interventions

tear of the distal tendon in the biceps muscle

Countries

Not provided

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

Dec 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 27, 2011

First Submission Date that Met QC Criteria

Apr 27, 2011

First Posted Date

Apr 28, 2011Estimated

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 25, 2011

Last Update Posted Date

Dec 28, 2011Estimated

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

Background: rupture of the distal tendon in biceps muscle is a rare injury. The state of the art treatment is surgical procedure.

Objective: Evaluation of the Surgical procedure among patients that suffered from Methods: The investigators will review files from 2003-2010 of patients that gone through the operation. The investigators will record pre-operation and post-operation process including complications and rehabilitation. The investigators will invite them to the clinic for exams, clinical questionnaires.

Detailed Description

Not provided

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

Not provided

Label	Type	Description	Intervention Names
surgery, biceps tear			Procedure: tear of the distal tendon in the biceps muscle

Name	Type	Description	Arm Group Labels	Other Names
tear of the distal tendon in the biceps muscle	Procedure		surgery, biceps tear

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1.see population description

Exclusion Criteria:

1. Unwillingness to come to the clinic visit.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

men and women that went to surgery due to tear of the distal tendon in the biceps muscle.

Sampling Method

Non-Probability Sample