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.: PACTR201711002617194 Date of Approval: 11/09/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Treatment of sub-acromial impingement syndrome utilizing arthroscopic vs open sub-acromial decompression
Official scientific title Treatment of sub-acromial impingement syndrome utilizing arthroscopic vs open sub-acromial decompression
Brief summary describing the background and objectives of the trial Aim of the work To compare effectiveness and benefits between arthroscopic and open subacromial decompression in treatment of subacromial impingemen syndrome. Patients and methods The study will be conducted in Beni Suef university hospital, after approval from the local ethical committee and an informed consent for any one of the two techniques. Methodology Preoperative assessment The patient will be assessed radiological by plain x-ray (anteroposterior (AP), outlet and axillary views) and MRI for proper evaluatation of subacomial space. Clinically the patient will be assessed using the American Shoulder and Elbow Surgeons¿ Score (ASES) 20 . This scoring system consists of four variables that are used to assess the function of the shoulder. The subjective variables are pain and activity of daily living (ADL) (sleep, work, recreation / sport) which give a total of 35 points. The objective variables are range of motion and strength which give a total of 65 points. All together there are a total of 100 points. Techniques Arthroscopic surgery The arthroscopic subacromial decompression will be performed according to Ellman 21 with the patient in the lateral decubitus position. A traction device will be applied to the arm, and a tension to the arm corresponding to 40 N will be applied. The shoulder will be in 10° of flexion and 40° of abduction. The bony landmarks of the shoulder (the acromion, the clavicle, the acromioclavicular joint, the coracoids and the coracoacromial ligament) will be marked with a
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Skin and Connective Tissue Diseases,subacromial impingement
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 03/07/2016
Actual trial start date 03/07/2016
Anticipated date of last follow up 02/07/2017
Actual Last follow-up date 02/07/2017
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 60
Recruitment status Stopped early/ terminated
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table from a statistics book Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group arthroscopic subacromial decopmression follow up for one year arthroscopic subacromial decopmression 30 Active-Treatment of Control Group
Experimental Group open subacromial decopmression One year open subacromial decopmression 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Subacromial impingement syndrome in patients above 20 years old. Other associated shoulder pathology e.g rotator cuff tear and calcific tendonitis. Arthritic changes of glenohumeral joint. Combined infection. Neurological abnormality including axillary nerve. Adhesive capsulitis. ¿ Prior surgery or infection on shoulder girdle. 18 Year(s) 70 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 19/03/2017 Ethics committee of Faculty of medicin Beni Suef university (FM-BSU REC)
Ethics Committee Address
Street address City Postal code Country
Beni suef Beni suef 0020 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Learning curve Skills to perform arthroscopic diangnosis and therapy for shoulder joint
Primary Outcome Pain relived and function Istreatment of subacromial Impingement syndrome with Subacromial decompression effectively?
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni suef university hospital Beni Suef Beni Suef 0020 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Beni suef university Beni Suef Beni Suef 0020 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Beni suef university Beni Suef Beni Suef 0020 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Beni suef university Beni Suef Beni Suef 0020 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nasef Mohamed Nasef docnasef@hotmail.com 01223186563 Beni Suef
City Postal code Country Position/Affiliation
Beni Suef 0020 Egypt
Role Name Email Phone Street address
Public Enquiries Emad Garber elbanaemad@gmail.com 0122 453 1801 Beni Suef
City Postal code Country Position/Affiliation
Beni Suef 0020 Egypt
Role Name Email Phone Street address
Scientific Enquiries Ahmed Mohamed Hassaan Ahmedaiesh84@gmail.com 01226586156 Beni Suef
City Postal code Country Position/Affiliation
Beni Suef 0020 Egypt
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information