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OpenTrials
Completed

NCT Number: NCT00863473

Comminuted Proximal Humeral Fractures. A Randomised Study of Surgical Versus Conservative Treatment

1. Do a standardized surgical treatment of unstable displaced proximal humerus fracture in patients aged over 60 compared to a standardized conservative treatment gain a better functional outcome after one year? 2. Do surgical treatment gain more QALY than conservative treatment after one year?

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Key information

Conditions

Proximal Humeral Fracture Fractures, Bone Osteosynthesis or Conservative Treatment Shoulder Fractures Shoulder Injuries Wounds and Injuries

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tore Fjalestad, Ortopeadic Dept, Oslo University Hospital

Oslo, N-0514, Norway

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • proximal humerus fracture of AO group B2 or C2 (displaced fracture of extra-articular or articular, bifocal type) admitted in hospital

Exclusion criteria

  • aged less than 60 year
  • patients of non-Scandinavian ethnicity
  • previous history of injury or illness of the injured or contralateral shoulder
  • injury of other part of the humerus or the contralateral upper extremity,
  • alcohol- or drug abuse
  • dementia or neurological diseases
  • severe cardiovascular disease that would contraindicate surgery

Treatment and study plan

Surgical treatment with LCP

Procedure

Primary outcomes

  1. Functional shoulder score according to Constant (Original described Differences between the injured and uninjured shoulder as well as Adjusted according to age and gender).

    Time frame: 12 and 24 months

Secondary outcomes

  1. QALY (HRQoL score according to Harri Sintonen 15D and Costs)

    Time frame: 12 and 24 months

  2. ASES score (modified self assessment) C) Radiographic score

    Time frame: 12 and 24 months

  3. Radiographic score

    Time frame: 12 and 24 months

Sponsors and collaborators

Lead sponsor

University Hospital, Aker

Other

Collaborators

  • University of Oslo

Registry information

Official study title

Health and Cost Consequenses of Surgical Versus Conservative Treatment for a Comminuted Humerus Fracture. Do Interlocking Plate Surgery Benefit Displaced Proximal Humerus Fractures? A Randomized Clinical Trial

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Mar 18, 2009
Registry last updated
Apr 23, 2015

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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