Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
09/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr D Stanley

ORCID ID

Contact details

Orthopaedics
Northern General Hospital NHS Trust
Herries Road
Sheffield
S5 7AU
United Kingdom
+44 (0)114 271 4025

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

http://www.doh.gov.uk

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

  1. 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.

  2. 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.

Additional files

Editorial Notes