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

Completed

• Conditions: Fracture
• Interventions: Procedure: Winsta PH osteosynthesis device

• Registration Number: NCT00408291
• Lead Sponsor: University of Aarhus

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).

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)

Study Timeline

• Study First Submitted: 2006-12-05
• Study First Submitted QC: 2006-12-05
• Study First Posted: 2006-12-06
• Study Start: 2011-12
• Primary Completion: 2022-04
• Study Completion: 2023-03
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Winsta PH osteosynthesis device	Winsta PH osteosynthesis device (Fischer Medical)for treatment of humeral fracture

Primary Outcome Measures

Name	Time	Method
Healing (migration) of tuberculum majus and minus measured with use of Model-Based Roentgen Stereophotogrammetric Analysis (MB-RSA)	five years	Migration of the tubercles measured with Model-Based Roentgen Stereophotogrammetric Analysis (MB-RSA)

Secondary Outcome Measures

Name	Time	Method
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
Correlation between bone density and prosthesis migration (and tuberculum migration)	five years

Trial Locations

Locations (1)

Orthopaedic Department K, Silkeborg Hospital; 🇩🇰 Silkeborg, Denmark