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: pactr.samrc.ac.za
Trial no.: PACTR201205000381245 Date of Approval: 10/05/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
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 Proximal Humeral Fractures
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/06/2005
Actual trial start date 01/06/2005
Anticipated date of last follow up 01/02/2012
Actual Last follow-up date 01/02/2012
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 45
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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
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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tenodesis of the Long Head of the Biceps Tenodesis of the Long Head of the Biceps 23
Control Group Long Head of the Biceps left intact Long Head of the Biceps left intact (ie without tenodesis) 22
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum 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 Year(s) 60 Year(s) 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 30/05/2005 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 Street address
Principal Investigator Omar Soliman omarsoli@hotmail.com 002-012-22150083 22 Mosadak Street, Dokki
City Postal code Country Position/Affiliation
Geiza 12411 Egypt Ass Professor of Orthopaedic Surgery, Faculty of Medicine Cairo University, Egypt
Role Name Email Phone Street address
Public Enquiries Wael Koptan waelkoptan@gmail.com 002-012-23118522 60 Gezzirat El Arab Street, Mohandeseen
City Postal code Country Position/Affiliation
Geiza 12411 Egypt Professor of Orthopaedic Surgery, Faculty of Medicine Cairo University, Egypt
Role Name Email Phone Street address
Scientific Enquiries Wael Koptan waelkoptan@gmail.com 002-012-23118522 60 Gezzirat El Arab Street, Mohandeseen
City Postal code Country Position/Affiliation
Geiza 12411 Egypt Professor of Orthopaedic Surgery, Faculty of Medicine Cairo University, Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information