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

University of Aarhus

Status: Completed

Conditions: Fracture

Treatments: Procedure: Winsta PH osteosynthesis device

Study type: Observational

Funder types: Other

Identifiers

NCT00408291

20060166

Details and patient eligibility

About

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).

Full 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)

Enrollment: 36 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

36 participants in 1 patient group

1

Description:

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

Treatment:

Procedure: Winsta PH osteosynthesis device