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.: PACTR202512596688873 Date of Registration: 24/12/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Does the Type Of Tibial Medullary Guide For Tibial Resection Influence the Accuracy In Total Knee Arthroplasty?
Official scientific title Accuracy of intramedullary versus extra medullary cutting jigs in total knee arthroplasty
Brief summary describing the background and objectives of the trial In a standard total knee replacement, tibial component alignment is a key factor for the long-term success of the surgery. Performing a total knee replacement (TKR) requires the accurate execution of key bone cuts in the correct orientation to the appropriate axes. There is huge potential for cumulative errors to occur, which may have significant and dramatic effects on function and longevity. Good alignment helps to balance the forces transmitted to the soft-tissue envelope, which is crucial for proper function of the joint. The Debate on the optimal system is largely resolved, bit there is still controversy about whether intramedullary or extramedullary system are better for the tibial component. The purpose of this study is to compare the accuracy of extramedullary and intramedullary tibial cutting guides used in implants, in positioning of the tibial components in total knee arthroplasty.
Type of trial RCT
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 19/10/2016
Actual trial start date 19/10/2016
Anticipated date of last follow up 01/10/2017
Actual Last follow-up date 01/12/2017
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 160
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 Randomised Permuted block randomization Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Total Knee arthroplasty using Extramedullary guides for tibial cutting jigs for tibial cuts 10 minutes We use a tibial cutting jig that use the extra medullary anatomical landmarks as reference for performing accurate tibial cutting jigs. it depends on the transmalleollar line 80 Active-Treatment of Control Group
Experimental Group Total Knee arthroplasty using Intramedullary guides for tibial cutting jigs for tibial cuts 10 minutes of the procedure We use a tibial cutting jig that use the Intramedullary medullary and intra articular anatomical landmarks as reference for performing accurate tibial cutting jigs. it depends on the tibial spine location to perform the entry and then use the intramedullary rod as guide for placement of tibial cutting jigs. 80
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Knee osteoarthritis age 40-70 years old Tibial deformity retained intramedullary implants revision cases Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 70 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 19/10/2016 Assiut faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Assiut University faculty of medicine , Assiut , Egypt Assiut 71111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Measuring the tibial component angle 1 in Anteroposterior Postoperative plain Xray. then comparing the outcomes to identify which of these 2 methods proved to be more accurate than the other. Postoperative after the postoperative xrays was obtaine about 6 hours postoperative
Secondary Outcome Tibial component angle 2 Immediate postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assiut University Hospitals and Faculty of medicine Assiut University Assiut 71111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Research Team Assiut University faculty of medicine department of orthopaedics and trauma assiut 71111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Moustafa Kamal El Gafary Tag sultan compound Cairo 11351 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moustafa Kamal Ahmed Mohamed moustafak.elgafary@hotmail.com +201061883839 TAG SULTAN COMPOUND CAIRO EGYPT
City Postal code Country Position/Affiliation
CAIRO 11351 Egypt Assiut University
Role Name Email Phone Street address
Scientific Enquiries Moustafa Kamal Ahmed Mohamed moustafak.elgafary@hotmail.com +201061883839 TAG SULTAN COMPOUND
City Postal code Country Position/Affiliation
CAIRO 11351 Egypt Assiut University
Role Name Email Phone Street address
Public Enquiries Moustafa Kamal Ahmed Mohamed moustafak.elgafary@hotmail.com +201061883839 TAG SULTAN COMPOUND
City Postal code Country Position/Affiliation
CAIRO 11351 Egypt Assiut University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data (IPD) underlying the study results will be available upon reasonable request from the corresponding author, following ethics approval and a data-sharing agreement. No identifiable information will be shared. Informed Consent Form,Study Protocol IPD will be available 12 months after publication and remain accessible for up to 2 years. Access to the de-identified IPD will be granted to qualified researchers who submit a methodologically sound proposal. Data will be shared after approval from the principal investigator and, when required, the institutional ethics committee. A data-sharing agreement ensuring confidentiality and secure data handling must be signed before access is provided.
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 10/12/2025 Corrected was entered mistakenly 01 Jan 2024 19 Oct 2016
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 10/12/2025 Corrected was entered mistakenly 01 Jul 2024 19 Oct 2016
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 10/12/2025 Corrected was entered mistakenly 01 Dec 2025 01 Oct 2017
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 10/12/2025 Corrected was entered mistakenly 01 Dec 2025 01 Dec 2017
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 10/12/2025 Corrected was entered mistakenly 94 200
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 17/12/2025 Some Patients changed their decision about the procedure , some patients refused the surgery center and other had incomplete data so were excluded from the study. 200 160
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 10/12/2025 trial was completed (Corrected) Active, not recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 10/12/2025 Corrected to match the correct count of the trial number of participants Control Group, Total Knee arthroplasty using Extramedullary guides for tibial cutting jigs for tibial cuts, , 10 minutes, We use a tibial cutting jig that use the extra medullary anatomical landmarks as reference for performing accurate tibial cutting jigs. it depends on the transmalleollar line, 100, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 17/12/2025 Some patients changed their decision about the surgery. Control Group, Total Knee arthroplasty using Extramedullary guides for tibial cutting jigs for tibial cuts, , 10 minutes, We use a tibial cutting jig that use the extra medullary anatomical landmarks as reference for performing accurate tibial cutting jigs. it depends on the transmalleollar line, 80, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 10/12/2025 corrected to be matching the actual number of participants at the trial Experimental Group, Total Knee arthroplasty using Intramedullary guides for tibial cutting jigs for tibial cuts, , 10 minutes of the procedure, We use a tibial cutting jig that use the Intramedullary medullary and intra articular anatomical landmarks as reference for performing accurate tibial cutting jigs. it depends on the tibial spine location to perform the entry and then use the intramedullary rod as guide for placement of tibial cutting jigs., 80, Experimental Group, Total Knee arthroplasty using Intramedullary guides for tibial cutting jigs for tibial cuts, , 10 minutes of the procedure, We use a tibial cutting jig that use the Intramedullary medullary and intra articular anatomical landmarks as reference for performing accurate tibial cutting jigs. it depends on the tibial spine location to perform the entry and then use the intramedullary rod as guide for placement of tibial cutting jigs., 100,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 17/12/2025 corrected to be matching the actual number of participants at the trial Experimental Group, Total Knee arthroplasty using Intramedullary guides for tibial cutting jigs for tibial cuts, , 10 minutes of the procedure, We use a tibial cutting jig that use the Intramedullary medullary and intra articular anatomical landmarks as reference for performing accurate tibial cutting jigs. it depends on the tibial spine location to perform the entry and then use the intramedullary rod as guide for placement of tibial cutting jigs., 100, Experimental Group, Total Knee arthroplasty using Intramedullary guides for tibial cutting jigs for tibial cuts, , 10 minutes of the procedure, We use a tibial cutting jig that use the Intramedullary medullary and intra articular anatomical landmarks as reference for performing accurate tibial cutting jigs. it depends on the tibial spine location to perform the entry and then use the intramedullary rod as guide for placement of tibial cutting jigs., 80,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 10/12/2025 The Trial is done at its date and is not recruiting anymore , this is registered for the publication but not the RCT TRUE, Assiut faculty of Medicine Institutional Review Board, Assiut University faculty of medicine , Assiut , Egypt, Assiut, 71111, Egypt, , 19 Oct 2016, 0020882411900, IRB_asyut@aun.edu.eg, 39669_36846_4737.pdf TRUE, Assiut faculty of Medicine Institutional Review Board, Assiut University faculty of medicine , Assiut , Egypt, Assiut, 71111, Egypt, , 19 Oct 2016, 0020882411900, IRB_asyut@aun.edu.eg, 39669_36846_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 10/12/2025 Corrected NOT APPLICABLE, Assiut University faculty of medicine department of orthopaedics and trauma, assiut, 71111, Egypt, Hospital, Research Team, Assiut University faculty of medicine department of orthopaedics and trauma, assiut, 71111, Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Minimum age 10/12/2025 I received note from you to double check if I added all age groups 40 Year(s) 45 Year(s)