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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201410000899167 Date of Registration: 29/09/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Bone graft supplemented with PRP for scaphoid non-union
Official scientific title Distal Radius Bone Graft Supplemented with Autologous Platelet Gel versus Matti-Russe Technique for the Treatment of Scaphoid Non-union: A Randomized Control Clinical Trial
Brief summary describing the background and objectives of the trial The diagnosis of scaphoid nonunion is made on radiographs but CT or MRI scans may be useful to assess deformity and blood supply. Treatment options vary from percutaneous fixation to ORIF with vascularized or non-vascularized bone grafting, to salvage procedures involving excision and/or arthrodesis of carpal bones. Russe reported high rates of union with corticocancellous iliac crest bone grafts placed within the excavated scaphoid. Shah and Jones described 13 proximal pole scaphoid nonunions treated with a Herbert screw and autogenous cancellous distal radius bone graft. Pedicled vascularized bone grafts can be used and are derived from several different locations. The most commonly used bone grafts are from the distal radius. The results of the use of distal radial pedicle grafts vary greatly in terms of success, with union rates ranging from 27% to 100%. Autologous Platelet-rich plasma (PRP) has been shown to increase the rate of bone maturation and to improve bone density when added to small bony defects, or to larger defects in combination with grafting material.It can be used to deliver high concentrations of osteoinductive growth factors, such as platelet derived growth factors, including transforming growth factor and vascular endothelial growth factor, to bony and soft tissue sites, initiating and/or augmenting the healing response of the body. Since PRP is an autologous biologic material, it involves a minimum risk of immune reactions and transmission of infectious and contagious diseases, and it has been widely used for the recovery of musculoskeletal lesions. Therefore, this study aims to prospectively compare the radiological and clinical outcomes of the use of distal radius bone graft supplemented with autologous platelet gel versus modified Matti-Russe technique for the treatment of scaphoid non-union.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics,Scaphoid Non-union,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/10/2014
Actual trial start date
Anticipated date of last follow up 30/09/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Recruiting
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 Each participant will be randomly assigned following simple randomization procedure by using closed white envelops: 30 envelops assign the group to be followed. Those envelops include 15 paper charts (Fig. A) and 15 paper charts (Fig. B), which are folded three times not to show its contents to assure random assignment. WITH Matti-Russe technique Figure A: Paper inside the closed white envelopes. WITH cancellous distal radius bone graft supplemented with autologous platelet gel Figure B: Paper inside the closed white envelopes. Sealed opaque envelops Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Matti-Russe technique once The fracture site will be replaced with a plug of corticocancellous graft harvested from the iliac crest, and reshaped to better fit the excavated cavity. After assessing the fracture alignment with a C-arm, internal fixation with a Herbert screw will be performed. 15 Active-Treatment of Control Group
Experimental Group Cancellous distal radius bone graft supplemented with autologous platelet gel once After the preparation of the scaphoid cavity, cancellous bone will be harvested from the distal end of the radius and impregnated with the platelet gel. Intra-operative radiographs will be obtained and any humpback deformity will be corrected corrected. Herbert screw will be inserted parallel to the longitudinal axis of the scaphoid. The cavity is then filled with the prepared graft. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Male and female patients - Ages > 18 years - Symptomatic scaphoid non-union or pseudoarthrosis longer than 6 months - No previous scaphoid surgeries - No medical contraindications to surgery - Patients with wrist osteoarthritic changes 18 Year(s) 80 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 12/09/2014 High Research Ethics Committee, Faculty of Medicine, Suez Canal University
Ethics Committee Address
Street address City Postal code Country
4.5 Km Ring road Ismailia 41111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Radiological outcome based on bone healing (confirmed by presence of bridging bony trabeculae), The radiolunate and scapholunate angles - Immediate poetoperative - 3 weeks postoperative - 6 weeks postoperative - 12 weeks postoperative
Secondary Outcome Clinical outcome based on the Green and O¿Brien scoring system modified by Cooney, ROM and grip strength - 6 Weeks after surgery - 12 Weeks after surgery - 6 Months after surgery - One year after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hand Surgery Unit, Department of Orthopedic surgery and Trauma, Suez Canal University Hospitals 4.5 Km Ring Road Ismailia 41111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Governmental health insurance Ring Road, 5th Stage, El-Sheikh Zayed District Ismailia 41112 Egypt
Suez Canal University Hospitals, Clinical pathology department 4.5 Km Ring Road Ismailia 41111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Asser Sallam, MD, PhD 4.5 Km Ring Road, Suez canal University Hospitals, Department of Orthopedic surgery and Trauma Ismailia 41111 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohamed Salah, MD 4.5 Km Ring Road, Suez canal University Hospitals, Department of Orthopedic surgery and Trauma Ismailia 41111 Egypt
Noha Kamel, MD 4.5 Km Ring Road, Suez canal University Hospitals, Department of Orthopedic surgery and Trauma Ismailia 41111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Asser Sallam assersallam@hotmail.com +20 109 5277212 4.5 Km Ring Road, Suez Canal University Hospitals, Department of Orthopedic Surgery and Trauma
City Postal code Country Position/Affiliation
Ismailia 41111 Egypt Lecturer and consultant of Orthopedic surgery and Trauma
Role Name Email Phone Street address
Public Enquiries Asser Sallam assersallam@hotmail.com +20 109 5277212 4.5 Km Ring Road, Suez Canal University Hospitals, Department of Orthopedic Surgery and Trauma
City Postal code Country Position/Affiliation
Ismailia 41111 Egypt Lecturer and consultant of Orthopedic surgery and Trauma
Role Name Email Phone Street address
Scientific Enquiries Asser Sallam assersallam@hotmail.com +20 109 5277212 4.5 Km Ring Road, Suez Canal University Hospitals, Department of Orthopedic Surgery and Trauma
City Postal code Country Position/Affiliation
Ismailia 41111 Egypt Lecturer and consultant of Orthopedic surgery and Trauma
REPORTING
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Result URL Hyperlinks
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