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

Fracture Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00408291
• Other study ID #: 20060166
• Status: Completed
• Start date: December 2011
• Est. completion date: March 2023

Study information

• Verified date: January 2024
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2023
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone

Intervention

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

Locations

Country	Name	City	State
Denmark	Orthopaedic Department K, Silkeborg Hospital	Silkeborg

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation between bone density and prosthesis migration (and tuberculum migration)		five years
Secondary	Range of Motion (ROM)		five years
Secondary	Muscle strength		five years
Secondary	Activities of Daily Living (ADL)		five years
Secondary	Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry (DEXA)		five years