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

University of Aarhus36 enrolled

Overview

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).

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 Type

OBSERVATIONAL

Enrollment

Conditions

Fracture

Interventions

Winsta PH osteosynthesis devicePROCEDURE

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

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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 -

Locations (1)

Orthopaedic Department K, Silkeborg Hospital

Silkeborg, Denmark

Outcomes

Primary Outcomes

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)

Time frame: five years

Secondary Outcomes

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

Time frame: five years

Range of Motion (ROM)

Time frame: five years

Muscle strength

Time frame: five years

Activities of Daily Living (ADL)

Time frame: five years

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

Time frame: five years

Data from ClinicalTrials.gov

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