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Completed

NCT Number: NCT00408291

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

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).

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Key information

Conditions

Fracture Fractures, Bone Wounds and Injuries

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopaedic Department K, Silkeborg Hospital

Silkeborg, 8600, Denmark

About this study

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):

  • Pain
  • Activities of Daily Living (ADL)
  • Range of Motion (ROM)
  • Muscle strength

We shall measure the following radiologic parameters:

  • Healing (migration) of tuberculum majus and minus measured with use of MB-RSA
  • Plate migration with use of MB-RSA
  • Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry (DEXA)
  • Correlation between bone density and prosthesis migration (and tuberculum migration)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with three-part and four-part proximal humeral fractures
  • Aged 50 years or older and fit
  • Informed, written consent
  • A functioning shoulder preoperatively -

Exclusion criteria

  • Patients found unsuitable preoperatively for a shoulder Philos Plate
  • Patients aged 85 or older
  • Patients with rheumatoid arthritis
  • Patients who previously had undergone shoulder plastic or other major shoulder surgery
  • Patients unable to avoid NSAID after surgery
  • Patients requiring regular systemic steroid treatment
  • Female patients taking hormone substitution
  • Female patients in the fertile age range who do not use safe anti-conception (oral contraception, intrauterine devices, depot gestagens, vaginal hormone rings)
  • Patients with metabolic bone disease -

Treatment and study plan

Winsta PH osteosynthesis device

Procedure

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

Other names: Winsta PH osteosynthesis device (Fischer Medical)

Primary outcomes

  1. Healing (migration) of tuberculum majus and minus measured with use of Model-Based Roentgen Stereophotogrammetric Analysis (MB-RSA)

    Time frame: five years

    Migration of the tubercles measured with Model-Based Roentgen Stereophotogrammetric Analysis (MB-RSA)

Secondary outcomes

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

    Time frame: five years

  2. Range of Motion (ROM)

    Time frame: five years

  3. Muscle strength

    Time frame: five years

  4. Activities of Daily Living (ADL)

    Time frame: five years

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

    Time frame: five years

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2022
Study completion
2023
First posted
Dec 6, 2006
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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