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

Proximal Humeral Fracture Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00863473
• Other study ID #: AkerU_s422
• Status: Completed
• Phase: Phase 2
• First received: March 16, 2009
• Last updated: April 22, 2015
• Start date: May 2003
• Est. completion date: May 2010

Study information

• Verified date: April 2015
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Osteosynthesis or Conservative Treatment
• Proximal Humeral Fracture
• Shoulder Fractures

Intervention

Procedure:
• Surgical treatment with LCP

Locations

Country	Name	City	State
Norway	Tore Fjalestad, Ortopeadic Dept, Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Aker	University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Fjalestad T, Hole MØ, Hovden IA, Blücher J, Strømsøe K. Surgical treatment with an angular stable plate for complex displaced proximal humeral fractures in elderly patients: a randomized controlled trial. J Orthop Trauma. 2012 Feb;26(2):98-106. doi: 10.1097/BOT.0b013e31821c2e15. — View Citation

Fjalestad T, Hole MØ, Jørgensen JJ, Strømsøe K, Kristiansen IS. Health and cost consequences of surgical versus conservative treatment for a comminuted proximal humeral fracture in elderly patients. Injury. 2010 Jun;41(6):599-605. doi: 10.1016/j.injury.2009.10.056. Epub 2009 Nov 27. — View Citation

Fjalestad T, Hole MØ. Displaced proximal humeral fractures: operative versus non-operative treatment--a 2-year extension of a randomized controlled trial. Eur J Orthop Surg Traumatol. 2014 Oct;24(7):1067-73. doi: 10.1007/s00590-013-1403-y. Epub 2014 Jan 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional shoulder score according to Constant (Original described Differences between the injured and uninjured shoulder as well as Adjusted according to age and gender).		12 and 24 months	No
Secondary	QALY (HRQoL score according to Harri Sintonen 15D and Costs)		12 and 24 months	No
Secondary	ASES score (modified self assessment) C) Radiographic score		12 and 24 months	No
Secondary	Radiographic score		12 and 24 months	No