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

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00772850
First received: October 14, 2008
Last updated: July 14, 2010
Last verified: July 2010
History of Changes
  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:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Sonographic finding, functional recovery [ Time Frame: at least 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiographical finding [ Time Frame: at least 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 14, 2008
Last Updated: July 14, 2010
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Wounds and Injuries
Arm Injuries

ClinicalTrials.gov processed this record on June 13, 2013