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.: PACTR202404475835971 Date of Approval: 04/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Arthroscopic rotator cuff repair: Trans-osseous versus anchor technique
Official scientific title Outcomes of arthroscopic rotator cuff repair using trans-osseous technique versus anchor technique
Brief summary describing the background and objectives of the trial Rotator cuff tears are a leading cause of shoulder pain and functional impairment, affecting a significant portion of the adult population, especially among older adults and individuals engaging in repetitive overhead activities or sports. The management of rotator cuff tears has evolved significantly over the years, with surgical intervention being a common recourse for those suffering from symptoms that are refractory to conservative treatment. Among the surgical options available, Arthroscopic Transosseous (ATO) rotator cuff repair and the Suture-Anchor (SA) technique in a single-row configuration represent two primary methodologies. The ATO technique, characterized by its mimicry of the traditional open transosseous repair through arthroscopic means, promises a more anatomical restoration of the tendon to bone. It purports to offer the advantage of decreased suture material in the joint and potentially lower costs due to the elimination of anchors. Conversely, the SA technique has gained popularity for its ease of use, adaptability in various tear configurations, and strong initial fixation strength. However, debates regarding the long-term efficacy, cost-effectiveness, and complication rates of these methods persist. Given the ongoing debate between the effectiveness of these two techniques, this study aims to conduct a comprehensive comparison of the ATO and SA techniques in a single-row configuration. The primary objective is to determine whether the clinical outcomes, including pain relief, functional recovery, and tendon healing rates of the Arthroscopic Transosseous Rotator Cuff Repair technique, are comparable to those achieved with the Suture-Anchor method. Secondary objectives include assessing the cost-effectiveness, patient satisfaction, and complication rates associated with each technique.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/06/2023
Actual trial start date 01/07/2023
Anticipated date of last follow up 01/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Arthroscopic transosseous repair 2 years The patient's arm is suspended in traction in a lateral position. A diagnostic arthroscopy is performed through the posterolateral portal to inspect the glenohumeral joint. A biceps tenotomy may be performed if necessary. The arthroscope is then moved to the subacromial space to perform a bursectomy, clearing the area. The rotator cuff tear is assessed, and the footprint preparation is performed using standard techniques. An accessory lateral portal is created below the lateral end of the acromion to accommodate the "ArthroCuff" jig, which is used later to pass loop transport shuttle sutures. A superior portal is created in line with the medial footprint of the rotator cuff to assist in passing the entry awl for the jig, creating a pilot hole. This process also allows bone marrow to seep into the repair area, potentially aiding healing. The "ArthroCuff" jig is introduced through the lateral portal and used to create a transverse tunnel in the bone. A shuttle suture is then introduced, and the jig facilitates the passing of this suture through the tunnels. Two no. 2 FiberWires are passed through each tunnel using the shuttle loop, and the sutures are passed through the rotator cuff using a retrograde suture passer. The surgeon ties standard arthroscopic sliding knots, and depending on the case, different suture configurations may be applied. The system allows for a knotless setup, and the placement of the knots provides a broad area of compression for the cuff over the footprint. 30
Control Group Anchors 2 years Structure and Procedure: This repair method utilizes two rows of suture anchors, one medial (near the joint) and the other lateral (toward the outer side), to restore the tendon's original attachment point on the bone more accurately. Tendon Mobilization: Before installing the anchors, the surgeon must release and mobilize the torn tendon to ensure it can be reattached without excessive tension, especially to the lateral side of the tuberculum majus (a part of the shoulder blade). Suitability: This technique is recommended for tears where the tendon can be reattached laterally without significant tension. Anchor Placement: Initially, medial row anchors are installed near the joint margin, and sutures are passed through the tendon in a horizontal mattress fashion, at least 10–12 mm medial from the tear's lateral edge. Then, lateral row anchors are installed, and sutures are passed through the lateral side of the tendon in a simple suture configuration. Suture Tying: The lateral row sutures are tied first, followed by the medial row sutures, ensuring proper tension. Anchor Number and Spacing: The number of anchors used depends on the size of the tear, but adequate spacing between anchors is crucial to avoid the risk of anchor overcrowding and failure. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Rotator cuff tear MRI evidence of tear at least three months of symptoms duration inadequate response to conservative measures patients with massive rotator cuff tears irreparable tears frozen shoulder inflammatory or rheumatologic diseases glenohumeral osteoarthritis previous shoulder surgery Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 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 30/01/2018 Menoufia University Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Yaseen Abd Elghafar st Shebin El-Kom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome tear healing and complications 1 year after surgery
Secondary Outcome complications 2 year after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University Faculty of Medicine Yaseen Abd Elghafar Shebin ElKom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menoufia University Yaseen Abd Elghafar Shebin Elkom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Menoufia University Yaseen Abd El-Ghafa Shebin ElKom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mustafa Mesriga Mustafa.mesriga@med.menofia.edu.eg 01093873324 Yaseen Abd ElGhafar
City Postal code Country Position/Affiliation
Shebin Elkom 32511 Egypt Menoufia University
Role Name Email Phone Street address
Public Enquiries Ahmed Dewidar ahmed.dewedar.12@med.menofia.edu.eg 01094242423 Yaseen Abd El-ghafar st
City Postal code Country Position/Affiliation
Shebin Elkom 32511 Egypt Menoufia University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mesregah mohamed.mesregah@med.menofia.edu.eg 010424242424 Yaseen Abd Elghafar
City Postal code Country Position/Affiliation
Shebin Elkom 32511 Egypt Menoufia University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The study emphasizes transparency and accessibility of research data, underscoring the importance of making individual participant data available to foster further research and understanding. Following the commitment to data sharing, the study outlines the specifics of the data availability as follows: Upon the completion of the trial, all individual participant data collected, after undergoing a rigorous deidentification process to protect participant privacy, will be made accessible. This comprehensive approach ensures that every piece of data gathered during the trial can be utilized for further analysis, providing a rich resource for ongoing and future research endeavors. In addition to the raw data, a suite of essential documents will be shared, including the Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, and the Analytic Code. These documents offer valuable insights into the study’s methodology, analysis techniques, and ethical considerations, serving as a foundation for replicating the study or conducting related research. The availability of data is set to commence immediately following the publication of the study’s findings, without a predetermined end date. This open-ended approach facilitates ongoing access to the data, encouraging a wide range of analyses over time. The data and accompanying documents will be accessible to any interested party, promoting an inclusive approach that allows researchers, clinicians, and other stakeholders worldwide to engage with and analyze the data for various purposes. Whether for replicating the study, conducting meta-analyses, or exploring new research questions, the breadth of accessible data supports a wide spectrum of analytical endeavors. To access the data, a proposal can be submitted up to 36 months following the article's publication. This period offers ample time for interested parties to develop and submit their proposals for accessing the data. Study Protocol / /
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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