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Evaluation of Treatment of Fractures of the Humerus With a Plate.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by University of Aarhus.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00408291
First Posted: December 6, 2006
Last Update Posted: May 20, 2015
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 (Responsible Party):
University of Aarhus
December 5, 2006
December 6, 2006
May 20, 2015
December 2011
January 2016   (Final data collection date for primary outcome measure)
Healing (migration) of tuberculum majus and minus measured with use of MB-RSA [ Time Frame: five years ]
  • Healing (migration) of tuberculum majus and minus measured with use of MB-RSA
  • Prosthesis and plate migration with use of MB-RSA
  • Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry (DEXA)
  • Pain
  • Activities of Daily Living (ADL)
Complete list of historical versions of study NCT00408291 on ClinicalTrials.gov Archive Site
  • Correlation between bone density and prosthesis migration (and tuberculum migration) [ Time Frame: five years ]
  • Range of Motion (ROM) [ Time Frame: five years ]
  • Muscle strength [ Time Frame: five years ]
  • Activities of Daily Living (ADL) [ Time Frame: five years ]
  • Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry (DEXA) [ Time Frame: five years ]
  • Correlation between bone density and prosthesis migration (and tuberculum migration)
  • Range of Motion (ROM)
  • Muscle strength
Not Provided
Not Provided
 
Evaluation of Treatment of Fractures of the Humerus With a Plate.
Evaluation of the Winsta PH Osteosynthesis Device in the Treatment of Three- and Four-Part Fractures of the Proximal Humerus A Prospective Migration and Bone Density Study
The purpose of this study is to study with the use of clinical and radiological parameters the treatment of three-part and four-part fractures with the Winsta PH osteosynthesis device (Fischer Medical).

We shall measure the following clinical parameters with the help of the Constant Shoulder Score (CSS) and Western Ontario Osteoarthritis of the Shoulder Index (WOOS):

  1. Pain
  2. Activities of Daily Living (ADL)
  3. Range of Motion (ROM)
  4. Muscle strength

We shall measure the following radiologic parameters:

  1. Healing (migration) of tuberculum majus and minus measured with use of MB-RSA
  2. Plate migration with use of MB-RSA
  3. Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry (DEXA)
  4. Correlation between bone density and prosthesis migration (and tuberculum migration)
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
The study population will be included at 2 orthopaedic departments at 2 hospitals
Fracture
Procedure: Winsta PH osteosynthesis device
The Winsta PH osteosynthesis device have been developed for use in treatment of proximal humerus fractures.
Other Name: Winsta PH osteosynthesis device (Fischer Medical)
1
Winsta PH osteosynthesis device (Fischer Medical)for treatment of humeral fracture
Intervention: Procedure: Winsta PH osteosynthesis device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
January 2016
January 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with three-part and four-part proximal humeral fractures
  2. Aged 50 years or older and fit
  3. Informed, written consent
  4. A functioning shoulder preoperatively -

Exclusion Criteria:

  1. Patients found unsuitable preoperatively for a shoulder Philos Plate
  2. Patients aged 85 or older
  3. Patients with rheumatoid arthritis
  4. Patients who previously had undergone shoulder plastic or other major shoulder surgery
  5. Patients unable to avoid NSAID after surgery
  6. Patients requiring regular systemic steroid treatment
  7. Female patients taking hormone substitution
  8. Female patients in the fertile age range who do not use safe anti-conception (oral contraception, intrauterine devices, depot gestagens, vaginal hormone rings)
  9. Patients with metabolic bone disease -
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00408291
20060166
No
Not Provided
Not Provided
University of Aarhus
University of Aarhus
Not Provided
Study Director: Kjeld Soballe, Professor Orthopaedic Department, Aarhus University Hospital
University of Aarhus
July 2013