NCT00772850

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 15, 2010

Status Verified

July 1, 2010

Enrollment Period

1.7 years

First QC Date

October 14, 2008

Last Update Submit

July 14, 2010

Conditions

Keywords

Humeral fracture; Antegrade nailing; Rotator cuff

Outcome Measures

Primary Outcomes (1)

  • Sonographic finding, functional recovery

    at least 12 months

Secondary Outcomes (1)

  • Radiographical finding

    at least 12 months

Study Arms (1)

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.

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients operated in National Taiwan University hospital

You may qualify if:

  • 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.

You may not qualify if:

  • subjects refusing to take the examinations
  • subjects lost to follow up
  • subjected with pre-existing shoulder problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopedic Surgery, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (3)

  • Lin J, Hou SM. Antegrade locked nailing for humeral shaft fractures. Clin Orthop Relat Res. 1999 Aug;(365):201-10. doi: 10.1097/00003086-199908000-00025.

  • Lin J, Hou SM, Hang YS. Locked nailing for displaced surgical neck fractures of the humerus. J Trauma. 1998 Dec;45(6):1051-7. doi: 10.1097/00005373-199812000-00013.

  • Lin J. Treatment of humeral shaft fractures with humeral locked nail and comparison with plate fixation. J Trauma. 1998 May;44(5):859-64. doi: 10.1097/00005373-199805000-00019.

MeSH Terms

Conditions

Humeral Fractures

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Jinn Lin, MD, PhD

    Department of Orthopedic Surgery, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 14, 2008

First Posted

October 15, 2008

Study Start

October 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 15, 2010

Record last verified: 2010-07

Locations