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.: PACTR202009612835052 Date of Approval: 25/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Prospective Randomised Trial comparing Post-operative knee alignment following total knee replacement using patient specific knee instrumentation based on either CT or MRI.
Official scientific title A Prospective Randomised Trial comparing Post-operative knee alignment following total knee replacement using patient specific knee instrumentation based on either CT or MRI.
Brief summary describing the background and objectives of the trial The clinical objective for this investigation is to determine coronal and sagittal knee alignment following total knee replacement using patient specific instrumentation (PSI). A computer tomography (CT) based patient specific instrumentation protocol will be compared to a magnetic resonance image (MRI) based protocol. Ease of use and the incidence of complications will also be fully documented. Radiography will be used to determine the position of the implant and limb alignment. The short-term clinical efficacy of the knee replacement will be determined by the use of clinical and functional scores.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PSI001
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 29/05/2017
Actual trial start date 03/07/2017
Anticipated date of last follow up 11/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 70
Recruitment status Closed to recruitment,follow-up continuing
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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group CT PSI Intra-op Patient Specific Blocks based on pre-op CT scan of the knee 35 Active-Treatment of Control Group
Experimental Group MRI PSI Intra-op patient specific instrumentation based on pre-op MRI 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients suitable for primary Total Knee Replacement 2. Patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of: a. Osteoarthritis b. Avascular necrosis c. Inflammatory Arthritis d. Traumatic arthritis 3. Patients aged over 18 and up to 80 years of age 4. Patients with limited co-morbidity – ASA I – III 5. Patients must be able to understand instructions and be willing to return for follow-up 1. Patients with significant co-morbidity - ASA IV - V 2. Dementia and inability to understand and follow instructions 3. Neurological conditions affecting moment 4. Patients who are intolerant of placement in a CT or MRI gantry because of claustrophobia. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 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 30/06/2017 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
29 Princess of Wales Terrace, Parktown, 2193 Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Coronal and sagittal knee alignment following total knee replacement using PSI based on either CT scan or MRI. Post-op, within 3 months of surgery
Secondary Outcome 1. Oxford Knee Score at each post-operative visit. 2. Knee Society Score pre and post-operatively. 3. Knee injury and Osteoarthritis Outcome Score (KOOS). 4. Radiographic analysis at each post-operative visit. 5. Complications (including revisions/removals). 6. Clinical Composite Success Post-op, six weeks, six months, one year, two years
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Orthopaedic Division University of the Witwatersrand Wits Medical School, 7 York Road, Parktown Johannesburg 2193 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Johannesburg Arthroplasty Consortium 29 Princess of Wales Terrace, Parktown Johannesburg 2193 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Zimmer GmbH Sulzerallee 8, 8404 Winterthur Winterthur 8404 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Dr JRT Pietrzak 7 York Road, Parktown Johannesburg 2194 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lipalo Mokete lipalo@hotmail.com +27825706496 Orthopaedic Division, 7 York Road, Parktown, 2193
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Lecturer Consultant Orthopaedic Surgeon
Role Name Email Phone Street address
Public Enquiries Anna Grisillo Biscardi Biscardi Anna.Grisillo@wits.ac.za +27117172538 Orthopaedic Division
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Trial Coordinator
Role Name Email Phone Street address
Scientific Enquiries Anna Grisillo anna.grisillo@gmail.com +27117172538 Orthopaedic Division, 7 York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Trial Coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlies the results reported in a relevant article will be made available to be shared after deidentification Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The data will be available beginning nine months from the date of publication of the article and ending three years following publication The data will only be made available to Investigators and Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose
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