Clinical trial NCT00408291: Evaluation of Treatment of Fractures of the Humerus With a Plate.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fracture
Keywords: fracture
shoulder
bone density
healing
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2006-12-06
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be included at 2 orthopaedic departments at 2 hospitals

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)

Eligibility criteria: 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 -

Primary outcomes:
measure: Healing (migration) of tuberculum majus and minus measured with use of Model-Based Roentgen Stereophotogrammetric Analysis (MB-RSA)
timeFrame: five years
Secondary outcomes:
measure: Correlation between bone density and prosthesis migration (and tuberculum migration)
timeFrame: five years
measure: Range of Motion (ROM)
timeFrame: five years
measure: Muscle strength
timeFrame: five years
measure: Activities of Daily Living (ADL)
timeFrame: five years
measure: Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry (DEXA)
timeFrame: five years
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Orthopaedic Department K, Silkeborg Hospital
Study officials:
affiliation: Orthopaedic Department, Aarhus University Hospital
name: Kjeld Soballe, Professor
role: STUDY_DIRECTOR
References:
citation: Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.