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

NCT00408291 | Completed

• 1 other identifier: 20060166
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Fracture

Keywords

fracture; shoulder; bone density; healing

Outcome Measures

Primary Outcomes (1)

• Healing (migration) of tuberculum majus and minus measured with use of Model-Based Roentgen Stereophotogrammetric Analysis (MB-RSA)

  Migration of the tubercles measured with Model-Based Roentgen Stereophotogrammetric Analysis (MB-RSA)

  five years

Secondary Outcomes (5)

• Correlation between bone density and prosthesis migration (and tuberculum migration)

  five years

• Range of Motion (ROM)

  five years

• Muscle strength

  five years

• Activities of Daily Living (ADL)

  five years

• Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry (DEXA)

  five years

Study Arms (1)

1

Winsta PH osteosynthesis device (Fischer Medical)for treatment of humeral fracture

Procedure: Winsta PH osteosynthesis device

Interventions

Winsta PH osteosynthesis device PROCEDURE

The Winsta PH osteosynthesis device have been developed for use in treatment of proximal humerus fractures.

Also known as: Winsta PH osteosynthesis device (Fischer Medical)

1

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients found unsuitable preoperatively for a shoulder Philos Plate
• Patients aged 85 or older
• Patients with rheumatoid arthritis
• Patients who previously had undergone shoulder plastic or other major shoulder surgery
• Patients unable to avoid NSAID after surgery
• Patients requiring regular systemic steroid treatment
• Female patients taking hormone substitution
• Female patients in the fertile age range who do not use safe anti-conception (oral contraception, intrauterine devices, depot gestagens, vaginal hormone rings)
• Patients with metabolic bone disease -

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Orthopaedic Department K, Silkeborg Hospital

Silkeborg, 8600, Denmark

Location

Related Publications (1)

• Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

  PMID: 35727196 DERIVED

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Kjeld Soballe, Professor

  Orthopaedic Department, Aarhus University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2006
• First Posted: December 6, 2006
• Study Start: December 1, 2011
• Primary Completion: April 1, 2022
• Study Completion: March 1, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

DK (1)