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.: PACTR202308594339018 Date of Approval: 01/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of hamstring tendon periosteal wrapping on bone tendon healing and tunnel widening at 2 years follow up after anterior cruciate ligament anatomic reconstruction
Official scientific title Effect of hamstring tendon periosteal wrapping on bone tendon healing and tunnel widening at 2 years follow up after anterior cruciate ligament anatomic reconstruction
Brief summary describing the background and objectives of the trial Hamstring tendon autografts are one of the most commonly used graft for ACL reconstruction due to low morbidity, high tensile strength and versatility. However, concerns regarding bone graft integration remains a matter of scientific research. We propose a method that could improve graft to bone healing by wrapping the femoral end of the graft by periosteal flap that may enhance graft integration and prevent tunnel widening. The purpose of this study is to compare radiological findings using MRI and functional clinical outcome scores for a matched cohort of patients who underwent ACL reconstruction with hamstring autograft either with or without periosteal augmentation. We hypothesized that patients who underwent ACL reconstruction with periosteal augmentation would have better graft incorporation, healing and less tunnel widening with subsequently better functional outcomes at 2 years follow up.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/02/2017
Actual trial start date 01/02/2017
Anticipated date of last follow up 01/01/2023
Actual Last follow-up date 01/01/2023
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 54
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard ACL reconstruction using hamstring autografts - Anatomic ACL reconstruction using hamstring autografts 25 Active-Treatment of Control Group
Experimental Group Anterior cruciate ligament reconstruction with periosteal wrapping - Anterior cruciate ligament reconstruction with femoral end periosteal wrapping to enhance healing 27
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(1) skeletally mature male patients aged between 18-50 years old (2) isolated ACL injury confirmed both clinically ( positive Lachman, pivot shift and anterior drawer tests) and radiologically on MRI (3) healthy contralateral knee, (4) absence of previous injuries in the affected knee, (5) intact or repaired menisci at the time of surgery (6) low grade pivot shift (Grade 0-2) detected on examination under anesthesia, (7) Posterior tibial slope measured on lateral plain radiograph <10, (8) ACL graft diameter more than 8 mm and finally patients with less than 3 months interval between injury and surgery (1) posterior cruciate (PCL) and lateral collateral ligaments injuries, medial collateral ligament injuries higher than grade 2 (2) cartilage damage or signs of osteoarthritis (Outerbridge classification > 2) (3) meniscal deficiencies or meniscal tear that underwent partial meniscectomy. Adult: 19 Year-44 Year 18 Year(s) 55 Year(s) Male
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 12/01/2017 Tanta faculty of medicine ethical committe
Ethics Committee Address
Street address City Postal code Country
El-Gharbia Govenorate,Tanta . El-Gash st. Medical Campus The Faculty of Medicine Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Subjective outcomes - PROMs - IKDc score - Lysholm - Tegner scale , Objective score - MRI assessment of tunnel widening - graft healing and maturity 24 month
Secondary Outcome Correlation between functional scores and MRI findings 24 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University hospitals El-Gharbia Govenorate,Tanta . El-Gash st. Medical Campus The Faculty of Medicine Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of medicine El-Gharbia Govenorate,Tanta . El-Gash st. Medical Campus The Faculty of Medicine Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed 31 El Fatteh street Tanta 33331 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Helal ahmed.helal@med.tanta.edu.eg 00201017307693 31 El Fateh
City Postal code Country Position/Affiliation
Tanta 33331 Egypt Consultant of orthopedic surgery . Tanta University
Role Name Email Phone Street address
Public Enquiries Osama Elgebaly osama.elgebaly@med.tanta.edu.eg 00201227976884 El-Gharbia Govenorate,Tanta . El-Gash st. Medical Campus The Faculty of Medicine
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of orthopedic surgery
Role Name Email Phone Street address
Scientific Enquiries Sayed elforse elsayed.elfaras@med.tanta.edu.eg 00201288088078 El-Gharbia Govenorate,Tanta . El-Gash st. Medical Campus The Faculty of Medicine
City Postal code Country Position/Affiliation
tanta 31527 Egypt Lecturer of orthopedic surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Clinical Study Report Beginning 9 months and ending 36 months following article publication. Researchers who provide a methodologically sound proposal should complete access request. After being approved by by an independent review committee against pre-specified criteria a Data Use Agreement is prepared and signed.
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