Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RBF 98X42
Study information
Scientific title
Acronym
Study hypothesis
To examine the functional outcome of patients sustaining a fractured proximal humerus, following early and late physiotherapy.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Injury, occupational diseases, poisoning: Musculoskeletal injury
Intervention
1.. Physiotherapy within one week of their interviews
2. Physiotherapy at three weeks following their injury.
Both groups will receive treatment by senior physiotherapists who will be following a physiotherapy protocol for treatment and home exercises. Functional outcome measurements will be taken at three intervals.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Outcome measure: SF-36 and C-MSA (Constant-Murley shoulder assessment)
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/1998
Overall trial end date
30/04/2001
Reason abandoned
Eligibility
Participant inclusion criteria
120 patients sustaining fractured proximal humerus
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
120
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/1998
Recruitment end date
30/04/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Orthopaedics
Sheffield
S5 7AU
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Trent (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12729121
2. 2007 2 -year follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/17399621
Publication citations
-
Results
Hodgson SA, Mawson SJ, Stanley D, Rehabilitation after two-part fractures of the neck of the humerus., J Bone Joint Surg Br, 2003, 85, 3, 419-422.
-
Hodgson SA, Mawson SJ, Saxton JM, Stanley D, Rehabilitation of two-part fractures of the neck of the humerus (two-year follow-up)., J Shoulder Elbow Surg, 16, 2, 143-145, doi: 10.1016/j.jse.2006.06.003.