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Cementless Versus Cemented Tibial Fixation in Posterior Stabilised Total Knee Replacement - a Randomised Trial

Cementless Versus Cemented Tibial Fixation in Posterior Stabilised Total Knee Replacement - a Randomised Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001024134
Enrollment
100
Registered
2019-07-17
Start date
2013-08-22
Completion date
2015-06-25
Last updated
2019-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This randomised study compared how tibial fixation affected component migration, bone remodelling and clinical outcomes in Posterior Stabilised Total Knee Replacements. 100 patients were randomised to receive TKRs with cemented or cementless tibial components. The hypothesis was that tibial fixation method would impact implant stability.

Interventions

Participants underwent Total Knee Replacement surgery, with all variables standardised except tibial component fixation, where one group was cemented and one cementless. Procedure duration was about 60 minutes of surgical time per case. The implants were monitored for migration, bone mineral density and subjective clinical scores including Oxford Knee Score, Short From 12 and pain scores. Physical materials used include Advanced Coated System Total Knee Replacement implants in cemented and ceme

Participants underwent Total Knee Replacement surgery, with all variables standardised except tibial component fixation, where one group was cemented and one cementless. Procedure duration was about 60 minutes of surgical time per case. The implants were monitored for migration, bone mineral density and subjective clinical scores including Oxford Knee Score, Short From 12 and pain scores. Physical materials used include Advanced Coated System Total Knee Replacement implants in cemented and cementless tibial models. Two experienced arthroplasty surgeons carried out the operations, all were done at Hollywood Private Hospital. Followup was conducted at 3, 12 and 24 months post surgery

Sponsors

THE JOINT STUDIO
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
50 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

diagnosis of osteoarthritis in the knee, requiring knee replacement

Exclusion criteria

valgus alignment osteoporosis osteopenia prior ipsilateral knee surgery patients taking bisphosphonates, corticosteroids or cytostatic agents

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026