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Rotator Cuff Injury in Antegrade Locked Nailing for Humeral Fractures (SRC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00772850
First Posted: October 15, 2008
Last Update Posted: July 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
The purpose of this study is to investigate the potential insults of rotator cuff muscle and the functional recovery of upper extremity function after antegrade nailing of humeral fractures.

Condition
Humeral Fractures

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Sonographic Evaluation of Rotator Cuff Injury in Antegrade Locked Nailing for Humeral Fractures

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Sonographic finding, functional recovery [ Time Frame: at least 12 months ]

Secondary Outcome Measures:
  • Radiographical finding [ Time Frame: at least 12 months ]

Estimated Enrollment: 50
Study Start Date: October 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Antegrade nailing, humeral fractures
We included patient's age and gender, fracture location, fracture cause, presence of nail removal, post-operative period and comorbidity or associated disease as independent variables. Fracture location was either humeral neck or humeral shaft. Humeral neck fractures were defined as fractures above surgical neck of the humerus. Meanwhile, humeral shaft fractures were defined as fractures below surgical neck of the humerus and 5 cm above the olecarnon fossa. Humeral shaft fractures were separated into three groups: proximal third shaft fractures, middle third shaft fractures and distal third shaft fractures. Fracture causes included simple falls and traffic accidents.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients operated in National Taiwan University hospital
Criteria

Inclusion Criteria:

  • subjects must sign and date informed consent
  • subjects must be over fifteen years old, of either sex
  • subjects suffered from acute humeral fractures or non-unions
  • subjects were treated by antegrade H-L nailing (United, Taipei, Taiwan)
  • subjects had solid union of fractures
  • postoperative time was at least 12 months subjects were operated between 2003 and 2006.

Exclusion Criteria:

  • subjects refusing to take the examinations
  • subjects lost to follow up
  • subjected with pre-existing shoulder problems.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00772850


Locations
Taiwan
Department of Orthopedic Surgery, National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jinn Lin, MD, PhD Department of Orthopedic Surgery, National Taiwan University Hospital
  More Information

Publications:
Responsible Party: Jinn Lin, Professor, Department of Orthopedic Surgery
ClinicalTrials.gov Identifier: NCT00772850     History of Changes
Other Study ID Numbers: 200804007R
First Submitted: October 14, 2008
First Posted: October 15, 2008
Last Update Posted: July 15, 2010
Last Verified: July 2010

Keywords provided by National Taiwan University Hospital:
Humeral fracture; Antegrade nailing; Rotator cuff

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Rotator Cuff Injuries
Wounds and Injuries
Arm Injuries
Rupture
Shoulder Injuries
Tendon Injuries