Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000987460
Ethics application status
Approved
Date submitted
6/06/2025
Date registered
5/09/2025
Date last updated
5/09/2025
Date data sharing statement initially provided
5/09/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fixed versus mobile bearing rotaglide knee replacements: A randomised trial with a 10-year follow-up
Scientific title
Fixed versus mobile bearing rotaglide knee replacements: A randomised trial with a 10-year follow-up in patients undergoing total knee replacement.
Secondary ID [1] 314574 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 337676 0
Condition category
Condition code
Musculoskeletal 334012 334012 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The long-term results of fixed versus mobile bearing rotaglide total knee replacements will be compared. The intervention will be delivered by fellowship trained knee surgeons and the minimum number of patients required for that study will be determined by the sample size calculation performed based on the Oxford score. The procedures will be performed at the North Bristol NHS Trust and the University Hospitals Coventry & Warwickshire. The duration of the operation will be 1.5 hours approximately. The fixed bearing medial rotaglide total knee replacement differs from the mobile bearing replacement due to the fact that there is no mobile bearing component.
Intervention code [1] 331199 0
Treatment: Surgery
Comparator / control treatment
Mobile bearing rotaglide total knee replacements will be considered as control group in this study. This will involve the placement of the prosthesis with a mobile rotating platform. Mobile bearing rotaglide total knee replacement allow the insert to rotate and translate slightly in relation to both the femoral component and the tibial tray during knee flexion and extension.
Control group
Active

Outcomes
Primary outcome [1] 341672 0
Knee pain and function assessed as a composite primary outcome.
Timepoint [1] 341672 0
8 months, 2, 5, 8 and 10 (primary timepoint) years post-operatively.
Secondary outcome [1] 448292 0
Secondary outcomes will include the assessment of complications (eg reoperations and component revisions) assessed as a composite secondary outcome.
Timepoint [1] 448292 0
The secondary outcomes will be assessed at 8 months, 2, 5, 8, 10 and 19 years post-operatively.
Secondary outcome [2] 449494 0
Knee pain and function assessed as a composite secondary outcome.
Timepoint [2] 449494 0
8 months, 2, 5, 8 and 10 years post-operatively.
Secondary outcome [3] 449495 0
Knee pain and function assessed as a composite secondary outcome
Timepoint [3] 449495 0
8 months, 2, 5, 8 and 10 years post-operatively.

Eligibility
Key inclusion criteria
Inclusion criteria were male or female patients under 70 years of age undergoing total knee replacement. Also, patients’ ability to provide consent form and cooperate throughout the study were necessary.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were inflammatory/rheumatoid arthritis, neuropathic arthropathy and / or active sepsis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes containing the randomized group will be opened intraoperatively. The patients will be informed of which group they were in after the operation. Written consent will be obtained from all patients.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size will be calculated based upon the primary outcome of this study (ie Oxford score), with a p value of 0.5 and power set to 90%. The student’s t-test will be used to compare the results between the fixed and mobile bearing groups, with the p value being 0.05. Survivorship will be analyzed by means of Kaplan-Meier’s method.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/01/2001
Date of last participant enrolment
Anticipated
Actual
16/02/2006
Date of last data collection
Anticipated
Actual
16/02/2025
Sample size
Target
300
Accrual to date
Final
207
Recruitment outside Australia
Country [1] 27095 0
United Kingdom
State/province [1] 27095 0

Funding & Sponsors
Funding source category [1] 319124 0
Commercial sector/Industry
Name [1] 319124 0
Corin LTD
Country [1] 319124 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Corin LTD
Address
Country
United Kingdom
Secondary sponsor category [1] 321585 0
None
Name [1] 321585 0
Address [1] 321585 0
Country [1] 321585 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317716 0
Southmead Local Research Ethics Committee
Ethics committee address [1] 317716 0
Ethics committee country [1] 317716 0
United Kingdom
Date submitted for ethics approval [1] 317716 0
11/12/2000
Approval date [1] 317716 0
14/12/2000
Ethics approval number [1] 317716 0
095/00

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141918 0
Mr Kostas Tsikopoulos
Address 141918 0
NBT North Bristol NHS Trust, Southmead Rd, Bristol BS10 5NB
Country 141918 0
United Kingdom
Phone 141918 0
+441174148131
Fax 141918 0
Email 141918 0
[email protected]
Contact person for public queries
Name 141919 0
Rachel Bray
Address 141919 0
NBT North Bristol NHS Trust, Southmead Rd, Bristol BS10 5NB
Country 141919 0
United Kingdom
Phone 141919 0
+441174148131
Fax 141919 0
Email 141919 0
[email protected]
Contact person for scientific queries
Name 141920 0
MR Kostas Tsikopoulos
Address 141920 0
NBT North Bristol NHS Trust, Southmead Rd, Bristol BS10 5NB
Country 141920 0
United Kingdom
Phone 141920 0
+441174148131
Fax 141920 0
Email 141920 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.