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

NCT00863473 | Completed Phase 2

• 1 other identifier: AkerU_s422
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Do surgical treatment gain more QALY than conservative treatment after one year?

Conditions

Proximal Humeral Fracture; Osteosynthesis or Conservative Treatment

Keywords

Proximal Humerus Fracture in elderly

Outcome Measures

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).

  12 and 24 months

Secondary Outcomes (3)

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

  12 and 24 months

• ASES score (modified self assessment) C) Radiographic score

  12 and 24 months

• Radiographic score

  12 and 24 months

Study Arms (2)

Conservative /Physiotherapy

NO INTERVENTION

Active training protocol with instructed physiotherapy and self excercises

Surgery with LCP T plate

ACTIVE COMPARATOR

Surgical treatment with interlocking plate

Procedure: Surgical treatment with LCP

Interventions

Surgical treatment with LCP PROCEDURE

Surgery with LCP T plate

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Aker: lead
• University of Oslo: collaborator

Study Sites (1)

Tore Fjalestad, Ortopeadic Dept, Oslo University Hospital

Oslo, N-0514, Norway

Location

Related Publications (3)

• Fjalestad T, Hole MO, Hovden IA, Blucher J, Stromsoe 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.

  PMID: 21804410 BACKGROUND

• Fjalestad T, Hole MO, Jorgensen JJ, Stromsoe 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.

  PMID: 19945102 BACKGROUND

• Fjalestad T, Hole MO. 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.

  PMID: 24413845 BACKGROUND

MeSH Terms

Conditions

Shoulder Fractures

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD Consultant

Study Record Dates

• First Submitted: March 16, 2009
• First Posted: March 18, 2009
• Study Start: May 1, 2003
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 23, 2015

Record last verified: 2015-04

Locations

NO (1)