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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00408291
First received: December 5, 2006
Last updated: July 15, 2013
Last verified: July 2013

December 5, 2006
July 15, 2013
December 2011
January 2014   (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 ] [ Designated as safety issue: No ]
  • Healing (migration) of tuberculum majus and minus measured with use of MB-RSA
  • Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry (DEXA)
  • Activities of Daily Living (ADL)
  • Prosthesis and plate migration with use of MB-RSA
  • Pain
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 ] [ Designated as safety issue: No ]
  • Range of Motion (ROM) [ Time Frame: five years ] [ Designated as safety issue: No ]
  • Muscle strength [ Time Frame: five years ] [ Designated as safety issue: No ]
  • Activities of Daily Living (ADL) [ Time Frame: five years ] [ Designated as safety issue: No ]
  • Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry (DEXA) [ Time Frame: five years ] [ Designated as safety issue: No ]
  • 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.
 
Recruiting
30
January 2015
January 2014   (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 -
Both
50 Years to 85 Years
No
Contact: Inger B Mechlenburg, MSc +45 65371093 inger.mechlenburg@ki.au.dk
Contact: Maiken Stilling, MD +45 89 49 74 66 maiken.stilling@ki.au.dk
Denmark
 
NCT00408291
20060166
No
University of Aarhus
University of Aarhus
Not Provided
Study Director: Kjeld Soballe, Professor Orthopaedic Department, Aarhus University Hospital
University of Aarhus
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP