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

This study is currently recruiting participants.
Verified January 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: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

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).


Condition Intervention
Fracture
 Procedure: Winsta PH osteosynthesis device

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Healing (migration) of tuberculum majus and minus measured with use of MB-RSA [ Time Frame: five years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: December 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Winsta PH osteosynthesis device (Fischer Medical)for treatment of humeral 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)

Detailed Description:

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)
  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population will be included at 2 orthopaedic departments at 2 hospitals

Criteria

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 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408291

Contacts
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

Locations
Denmark
Orthopaedic Department K, Silkeborg Hospital Recruiting
Silkeborg, Denmark, 8600
Contact: Thomas Klebe, MD     +45 87 22 27 66     kotmk@sc.aaa.dk    
Sub-Investigator: Inger Mechlenburg B Mechlenburg, MSc            
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Kjeld Soballe, Professor Orthopaedic Department, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00408291     History of Changes
Other Study ID Numbers: 20060166
Study First Received: December 5, 2006
Last Updated: January 11, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
fracture
shoulder
bone density
healing

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013