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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00408291

Enrollment

Registered

2006-12-06

Start date

2011-12-31

Completion date

2023-03-31

Last updated

2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture

Keywords

fracture, shoulder, bone density, healing

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)

Interventions

PROCEDUREWinsta PH osteosynthesis device

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

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 -

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Range of Motion (ROM)	five years
Muscle strength	five years
Correlation between bone density and prosthesis migration (and tuberculum migration)	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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026