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.: PACTR201609001776292 Date of Approval: 08/09/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title OLECRANON FRACTURE FIXATION: RANDOMIZED CONTROL CLINICAL TRIAL
Official scientific title SEMITUBULAR VERSUS LOCKING COMPRESSION PLATES IN OLECRANON FRACTURE FIXATION: RANDOMIZED DOUBLE BLIND CONTROL CLINICAL TRIAL
Brief summary describing the background and objectives of the trial Trauma in South Africa is a major economic burden to the state and individuals affected. Upper limp trauma affects the livelihood and function of patients. Olecranon fractures contribute 10% of upper limb trauma. The treatment of olecranon fractures depends on the fracture pattern, this may include tension band wire or plates with screws. With increasing cost of surgical appliances and implants, the most economical methods with proven good clinical outcomes have to be identified. OBJECTIVES:The purpose of this study is to do a randomized control clinical trial comparing semi-tubular plates to locking compression plates in fixation of olecranon fractures
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Olecranon fracture fixation,Orthopaedics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/06/2016
Actual trial start date 07/07/2016
Anticipated date of last follow up 01/06/2017
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
ETHICS COMMITTE 98/2016
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 Thirty opaque envelopes each containing a rectangular slip measuring 6cm X 4cm in length and breadth respectively will be designed. Fifteen rectangular slips will have the letters STP representing semitubular plate and another fifteen will have the letters LPS representing locking plate system Thirty opaque envelopes each containing a rectangular slip. Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group open reduction internal fixation N/A 12 months Semitubular plate 15 Active-Treatment of Control Group
Experimental Group open reduction internal fixation N/A 12 months Locking compression plate 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Isolated olecranon fractures Mayo type II Fracture dislocation elbow Ipsilateral/ same sided forearm injuries Pre-existing elbow pathology 18 Year(s) 75 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 05/05/2016 Faculty of Health Sciences Research Ethics Committe
Ethics Committee Address
Street address City Postal code Country
31 Bophelong Road Pretoria 0007 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome clinical outcome measure: Mayo Elbow Performance Score 6 weeks 6 months 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kalafong Provincial Tertiary Hospital Klipspriger Road, Atteridgeville Pretoria 0001 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Steve Biko Academic Hospital Bophelong Road Pretoria 0007 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MKA Molepo Klipspriger Road, Atteridgeville Pretoria 0001 South Africa Hospital
COLLABORATORS
Name Street address City Postal code Country
Kalafong Provincial Tertiary Hospital Klipspriger Road, Atteridgeville Pretoria 0001 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MAKETO MOLEPO mkamolepo@gmail.com 0828233105 Klipspringer Road, Atteridgeville
City Postal code Country Position/Affiliation
Pretoria 0001 South Africa Registrar
Role Name Email Phone Street address
Public Enquiries Maketo Molepo mkamolepo@gmail.com 0828233105 klipspringer road, atteridgeville
City Postal code Country Position/Affiliation
pretoria 0001 South Africa orthopaedics registrar
Role Name Email Phone Street address
Scientific Enquiries Nkosana Motsitsi silas.motsitsi@up.ac.za 0123731011 klipspringer road, atteridgeville
City Postal code Country Position/Affiliation
pretoria 0001 South Africa head of department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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