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.: PACTR201805003376209 Date of Approval: 08/05/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Outcome of intra-medullary nailing compared to conventional plating in middle third clavicle fractures - a prospective randomized controlled trial
Official scientific title Outcome of intra-medullary nailing compared to conventional plating in middle third clavicle fractures - a prospective randomized controlled trial
Brief summary describing the background and objectives of the trial Recently the Sonoma CRx¿ device (Sonoma Orthopedic Products Inc, 3589 Westwind Boulevard Santa Rosa, CA 95403) has become available. It is unique in the sense that it is flexible at the medial end and thus follows the normal curvature of the clavicle, but then becomes rigid after having been activated in the desired position. The device is also rotatory stable via distally activated grippers on the medial side and a locking screw at the lateral end. The device has been shown to be effective in initial reviews10, but no randomized controlled trials comparing its efficacy to conventional plating has been done11,12. Therefore, the purpose of this study was to compare the effectiveness of treating patients with displaced and/or shortened clavicle shaft fractures with either the Sonoma CRx¿ device or traditional anatomically contoured locked plating. The effectiveness of the treatment was assessed over a 1-year period and was based on union rate and functional capacity of the shoulder. Surgical time needed to place the device, incision size and hardware failure were also documented. We hypothesized that fixation of the fracture using the intramedullary device could be achieved through a smaller incision with less soft tissue dissection and that the union rate and functional outcomes would be comparable to that which is achieved by plating.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Musculoskeletal Diseases,Patients with clavicle fractures
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 07/07/2011
Actual trial start date 07/07/2011
Anticipated date of last follow up 30/01/2013
Actual Last follow-up date 30/01/2013
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 70
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
HREC NO: M11/05/012 Stellenbosch University
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 automated excell allocation program Simple randomisation using a radomisation table created by a computer software program Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised automated excell allocation program Simple randomisation using a radomisation table created by a computer software program Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nailing group Patient with a clavicle fracture were treated with a Sanoma CRx intamedullary nail. n/a one operation 35
Control Group Plating group Patient with a clavicle fracture were treated with a pre-contoured locked plate. One operation n/a 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The minimum age for participation was 16 years. Patients had to have been admitted to the hospital with a fracture of the shaft of the clavicle, as determined by the Allman classification1. In addition, the fracture had to, at least be shortened by a minimum of 15mm, had to be displaced 100%, and/or had to be comminuted. Patients with previous clavicle fractures, or who had sustained a pathological fracture, were excluded from the study. 16 Year(s) 100 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 06/07/2011 Health Research Ethics Committee, Stellenbosch University
Ethics Committee Address
Street address City Postal code Country
Francie van Zijl Drive Parrow, Cape Town 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Union rate of the fracture 1.5, 3, 6 and 12 months after surgery
Secondary Outcome Fucntional ability of the shoulder DASH and Constant Shoulder Scores 1.5, 3, 6 and 12 months after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tygerberg Academic Hopsital Francie Van Zijl Parrow, Cape Town 7505 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South Africa Orthopaedic Association - for reimbursement of travel cost of patients 21 Reid St Bloemfontein 9301 South Africa
Stellenbosch Univeristy Francie Van Zijl Drive Parrow, Cape Town 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor South Africa Orthopaedic Association - for reimbursement of travel cost of patients 21 Reid St Bloemfontein 9301 South Africa Charities/Societies/Foundation
Primary Sponsor Stellenbosch Univeristy Francie Van Zijl Drive Parrow, Cape Town 7505 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr PR King Francie Van Zijl Drive Parrow, Cape Town 7505 South Africa
Dr A Ikram Francie Van Zijl Drive Parrow, Cape Town 7505 South Africa
Dr MM Eken Francie Van Zijl Drive Parrow, Cape Town 7505 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Paul Reginald King docreg10@gmail.com +27219389266 Francie van Zijl Drive
City Postal code Country Position/Affiliation
Parrow, Cape Town 7505 Spain Orthopaedic Surgeon & PhD student
Role Name Email Phone Street address
Principal Investigator Ajmal Ikram AjmalIkram@icloud.com +27219389266 Francie van Zijl Drive
City Postal code Country Position/Affiliation
Parrow, Cape Town 7505 South Africa Orthopaedic Surgeon
Role Name Email Phone Street address
Principal Investigator Maaike Maria Eken maaike.eken@live.nl +27219389266 Francie van Zijl Drive
City Postal code Country Position/Affiliation
Parrow, Cape Town 7505 South Africa Orthopaedic Reseacher
Role Name Email Phone Street address
Principal Investigator Rob Lamberts roblam@sun.ac.za +27219389266 Francie van Zijl Drive
City Postal code Country Position/Affiliation
Parrow, Cape Town 7505 South Africa Head of Orthopaedic Research
Role Name Email Phone Street address
Public Enquiries Rob Lamberts roblam@sun.ac.za +27219389266 Francie van Zijl Drive
City Postal code Country Position/Affiliation
Parrow, Cape Town 7505 South Africa Head of Orthopaedic Research
Role Name Email Phone Street address
Scientific Enquiries Rob Lamberts roblam@sun.ac.za +27219389266 Francie van Zijl Drive
City Postal code Country Position/Affiliation
Parrow, Cape Town 7505 South Africa Head of Orthopaedic Research
REPORTING
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