Treatment of Comminuted Fractures of the Proximal Humerus. A Randomised, Controlled Study
This study is currently recruiting participants.
Verified January 2012 by Helsinki University
Sponsor:
Helsinki University
Collaborators:
Helsinki University Central Hospital
National Institute for Health and Welfare, Finland
Information provided by (Responsible Party):
Tuomas Lahdeoja, Helsinki University
ClinicalTrials.gov Identifier:
NCT00999193
First received: October 20, 2009
Last updated: January 22, 2012
Last verified: January 2012
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Purpose
Fractures of the proximal humerus are common in elderly patients. The optimal treatment of comminuted, displaced fractures is subject to controversy, and the results of operative treatment have not been shown to be superior to conservative treatment. The aim of the study is to compare locking plate osteosynthesis versus treatment with fracture hemiarthroplasty versus conservative treatment in a randomised, controlled protocol. The results of treatment are measured at 6 weeks, 3 months, 6 months, 12 months and 24 months. Main outcome measures are Pain at rest and activity (NRSs) and functional assessment of the shoulder with Constant Score. Secondary outcome measures are Simple Shoulder test (SST), Disabilities of the Arm, Shoulder and Hand (DASH), quality of life assessment (15D), subjective patient satisfaction and costs.
| Condition | Intervention | Phase |
|---|---|---|
|
Humeral Fracture |
Procedure: locking plate, ORIF Procedure: Hemiarthroplasty Other: Conservative treatment |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effectiveness and Cost-Effectiveness of Operative and Conservative Treatment of Comminuted Fractures of the Proximal Humerus. A Randomised, Controlled Study. |
Resource links provided by NLM:
Further study details as provided by Helsinki University:
Primary Outcome Measures:
- Pain at rest Numeric Rating Scale 0-10 (NRS) [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years ] [ Designated as safety issue: No ]
- Pain in active motion NRS [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years ] [ Designated as safety issue: No ]
- Constant Score [ Time Frame: 3 mo, 6 mo, 1 year, 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Simple Shoulder Test (SST) [ Time Frame: 3 mo, 6 mo, 1 year, 2 years ] [ Designated as safety issue: No ]
- Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: 3 mo, 6 mo, 1 year, 2 years ] [ Designated as safety issue: No ]
- Quality of life assessed with 15D [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years ] [ Designated as safety issue: No ]
- Subjective satisfaction [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years ] [ Designated as safety issue: No ]
- Complications [ Time Frame: 6 weeks, 3 mo, 6 mo, 1 year, 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 150 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Conservative Treatment |
Other: Conservative treatment
Immobilisation in a supporting brace for 3 weeks, then increasingly active rehabilitation program supported by a physiotherapist until 12 weeks of the injury.
|
| Experimental: ORIF w. locking plate, no luxation |
Procedure: locking plate, ORIF
Open reduction of the fracture (and GH joint), internal fixation with a locking plate. Tuberculum fragments are sutured to the plate with thick non-absorbable suture.
|
| Experimental: Hemiarthroplasty, no luxation |
Procedure: Hemiarthroplasty
Replacement of the humeral articular head with hemiprosthesis. Tubercles are sutured to the prosthesis with thick nonabsorbable sutures.
|
| Experimental: ORIF w. locking plate, Luxation-fracture |
Procedure: locking plate, ORIF
Open reduction of the fracture (and GH joint), internal fixation with a locking plate. Tuberculum fragments are sutured to the plate with thick non-absorbable suture.
|
| Experimental: Hemiarthroplasty, Luxation-fracture |
Procedure: Hemiarthroplasty
Replacement of the humeral articular head with hemiprosthesis. Tubercles are sutured to the prosthesis with thick nonabsorbable sutures.
|
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 65 years and older
- Acute trauma: 1. randomisation (op vs cons) within 7 days of injury.
3- or 4-part fracture with >5mm dislocation of the anatomic neck.
- AO classification C1-2 for non-luxation fractures
- AO classification C3 for luxation fractures
Exclusion Criteria:
- Head Splitting fracture
- Open fracture
- Additional fractures in the shoulder region
- Other injuries requiring surgical treatment
- Clinically significant injury of the brachial plexus or vasculature
- Pathological fracture associated with cancer
- History of a fracture of the clavicle, scapula or humerus, or history of a very significant disease or trauma of the shoulder region (hemiparesis, tumour, osteomyelitis, grave arthrosis etc)
- Rheumatoid Arthritis in the shoulder requiring active treatment
- Reduced co-operation or incapability for independent living (dementia, mental illness, drug- or alcohol abuse etc)
- unwillingness to accept some of the treatment options.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999193
Contacts
| Contact: Tuomas Lähdeoja, MD | +358-40-5406501 | tuomas.lahdeoja@hus.fi |
| Contact: Mika Paavola, MD, PhD | +358-50-4272481 | mika.paavola@hus.fi |
Locations
| Finland | |
| Töölö Hospital Trauma Center, Helsinki University Central Hospital, | Recruiting |
| Helsinki, Finland | |
| Contact: Jarkko Pajarinen, MD, PhD +358-50-4271930 jarkko.pajarinen@hus.fi | |
| Principal Investigator: Tuomas Lähdeoja, MD | |
Sponsors and Collaborators
Helsinki University
Helsinki University Central Hospital
National Institute for Health and Welfare, Finland
Investigators
| Principal Investigator: | Tuomas Lähdeoja, MD | Helsinki University |
| Study Director: | Mika Paavola, MD, PhD | Helsinki University |
| Study Director: | Jarkko Pajarinen, MD, PhD | Helsinki University |
| Study Chair: | Ilkka Sinisaari, Md, PhD | Helsinki University |
| Study Chair: | Vesa Savolainen, MD, PhD | Helsinki University |
| Study Chair: | Jan-Magnus Björkenheim, MD, PhD | Helsinki University |
| Study Chair: | Seppo Koskinen, MD, PhD | Helsinki University |
| Study Chair: | Robert Björkenheim, MD | Helsinki University |
More Information
No publications provided
| Responsible Party: | Tuomas Lahdeoja, MD, Helsinki University |
| ClinicalTrials.gov Identifier: | NCT00999193 History of Changes |
| Other Study ID Numbers: | HUS-428/13/03/02/08 |
| Study First Received: | October 20, 2009 |
| Last Updated: | January 22, 2012 |
| Health Authority: | Finland: Ethics Committee Finland: National Advisory Board on Health Care Ethics |
Keywords provided by Helsinki University:
|
Shoulder Fracture Locking Plate |
Hemiarthroplasty Conservative Comminuted Proximal Humerus Fracture |
Additional relevant MeSH terms:
|
Fractures, Bone Humeral Fractures Fractures, Comminuted Wounds and Injuries Arm Injuries |
ClinicalTrials.gov processed this record on May 19, 2013