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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201205000381245 Date registered: 2012/05/10
TRIAL DESCRIPTION
Public title Proximal Humeral Fractures Treated with Hemiarthroplasty. Does Tenodesis of the Long Head of the Biceps Improve Results?
Official scientific title Proximal Humeral Fractures Treated with Hemiarthroplasty. Does Tenodesis of the Long Head of the Biceps Improve Results?
Brief summary describing the background
and objectives of the trial
Pathology of the long head of the biceps (LHB) may be the cause of anterior shoulder pain after hemiarthroplasty for treatment of fractures of the proximal humerus. The currently available literature lacks adequate randomized trials examining whether tenodesis of the LHB improves results. The purpose of this study was to evaluate the effects of tenodesis of the LHB on the clinical outcome following hemiarthroplasty for fractures of the proximal humerus.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Treatment
Anticipated trial start date 2005-06-01
Actual trial start date 2005-06-01
Anticipated date of last follow up 2012-02-01
Actual date of last follow up 2012-02-01
Anticipated target sample size (number of participants) 20   
Actual target sample size (number of participants) 45   
Recruitment status Completed: recruitment & data analysis complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Single group: all participants receive same intervention throughout study Randomised A computer generated random number sequence After enrollment, cases were sequentially arranged and plotted on the random number table to determine to which group they will be assigned. Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group Long Head of the Biceps left intact Long Head of the Biceps left intact (ie without tenodesis) 22
Experimental group Tenodesis of the Long Head of the Biceps Tenodesis of the Long Head of the Biceps 23

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Patients with four- part fractures of the proximal humerus, fracture dislocations or head splitting fractures Patients presenting within the first five days after injury After 3 months postoperatively: - Tuberosity malposition - Inferior subluxation of the prosthesis - Loss of reduction of the greater tuberosity - Deep infection which slowed down the physiotherapy protocol and required surgical debridement 45 Years 60 Years Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2005/05/30 Committee for Clinical and Experimental Studies
Ethics Committee Address
Street address City Postal code Country
Cairo University Hospital - Kasr Al Ainy Cairo 11111 Egypt

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 'Costant' Scoring System 18 months postoperative
Secondary Outcome Pain 18 months postoperative

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospitals Kasr Al Ainy Cairo 11111 Egypt

FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo University Hospitals Kasr Al Ainy Cairo 11111 Egypt

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Hospitals Kasr Al Ainy Cairo 11111 Egypt University

COLLABORATORS
Name Street address City Postal code Country
Dr Omar Soliman 22 Mosadak Street, Dokki Geiza 12411 Egypt

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Prof Omar Soliman omarsoli@hotmail.com 002-012-22150083
Street address City Postal code Country Position / Affiliation
22 Mosadak Street, Dokki Geiza 12411 Egypt Ass Professor of Orthopaedic Surgery, Faculty of Medicine Cairo University, Egypt
Role Name Email Phone Fax
Public Enquiries Prof Wael Koptan waelkoptan@gmail.com 002-012-23118522
Street address City Postal code Country Position / Affiliation
60 Gezzirat El Arab Street, Mohandeseen Geiza 12411 Egypt Professor of Orthopaedic Surgery, Faculty of Medicine Cairo University, Egypt
Role Name Email Phone Fax
Scientific Enquiries Prof Wael Koptan waelkoptan@gmail.com 002-012-23118522
Street address City Postal code Country Position / Affiliation
60 Gezzirat El Arab Street, Mohandeseen Geiza 12411 Egypt Professor of Orthopaedic Surgery, Faculty of Medicine Cairo University, Egypt