Skip to content

Fixation of polyethylene knee replacement tibial components in patients with osteoarthritis aged 18-60

Migration characteristics of the Profix all-polyethylene tibial component in patients with osteoarthritis aged 18-60

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000107224
Enrollment
21
Registered
2018-01-24
Start date
2006-03-01
Completion date
2009-07-23
Last updated
2019-12-10

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

Conditions

None listed

Brief summary

All-polyethylene (AP) tibial components in patients aged greater than 60 years have stable tibial migration patterns and favorable survival rates when compared to identical metal-backed (MB) designs. Tibial component fixation in patients aged less than 60 years was measured with radiostereometric analysis (RSA) and compared to a previous cohort of AP and MB tibial components of identical design in patients aged greater than 60 years. Methods A prospective consecutive study examined tibial component migration in 21 patients aged less than 60 years undergoing a cemented total knee arthroplasty with an AP tibial component by RSA to 24 months. Results were compared to the authors previous series of 21 patients aged greater than 60 years that were randomized to either an AP or MB tibial component. The articulating geometry and stem design of the implants were identical as were the operative technique and post-operative regime Results At 2-years both age groups of patients implanted with an all-polyethylene component had stable migration patterns with no patient having greater than 0.2 degree rotation or 0.5mm maximum total point motion. Five of 11 metal-backed tibial components displayed continued migration between 1 and 2 years. Median internal/external rotation was greater with MB components; 0.15, 0.08, 0.28, AP < 60 years, AP > 60 years, and MB cohorts. Subsidence significantly greater for MB implants; median subsidence 0.17, 0.10, 0.25, AP < 60 years, AP > 60 years, and MB cohorts. Median maximum total point motion was greater for the MB cohort 0.34, 0.33, 0.61mm, AP < 60 years, AP > 60 years, and MB cohorts Conclusions Young patients implanted with an all-polyethylene tibial component had stable tibial migration patterns comparable to older patients with the same all-polyethylene implant. Regardless of age, all-polyethylene tibial components were at least as stable as metal-backed tibial components. The study will continue until 10-years.

Interventions

Routine total knee replacement using a Profix (Smith & Nephew, USA) implant. All-polyethylene implant used in all patients. Standard surgical procedure of 60-90 minutes duration.

Sponsors

David Campbell
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

osteoarthritic patients booked to have knee replacement surgery

Exclusion criteria

previous surgery weight > 120kg inflammatory arthritis severe anatomical abnormalities non-metropolitan residence

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026