Comparison of patient pain levels between total knee replacement recipients who undergo kneecap resurfacing and those who don't.

Assessment of patient knee pain following randomised patellar resurfacing versus retention in anatomically designed total knee arthroplasty.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000759998

Enrollment

Registered

2020-07-24

Start date

2020-07-31

Completion date

2022-07-29

Last updated

2020-08-03

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 will be a randomised prospective study aiming to evaluate and compare patient reported outcome measures (PROMs) in patients who have their patella resurfaced during Total Knee Arthroplasty (TKA) and those who don’t. Patients will be randomised by computer generated block randomisation to receive patella resurfacing or not to receive patella resurfacing. The four surgeons performing the arthroplasty procedure are experienced in both interventions.Patients will be blinded to the intervention. We hypothesis that there will be no statistically significant difference between patients who undergo patella resurfacing during a SAIPHTM knee replacement and those who do not undergo resurfacing.

Interventions

Participants enrolled in this study who are randomised to the intervention group will undergo resurfacing of their patella at the time of receiving a total knee replacement. Patients will receive the SAIPH(TM) knee system for their femoral and tibial components. The surgical technique for the total knee replacement will be as per the surgeon's preference of the manufacturer's recommendations. A total knee replacement procedure generally takes approximately 90 minutes, with an additional 10 minutes for patella resurfacing. This intervention will be delivered as a single stage surgery by an experienced knee arthroplasty surgeon at St John of God Hospital, Murdoch. Follow up will occur for 12 months after the intervention.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1) Adult participants greater than >18 years of age 2) Participants undergoing primary knee arthroplasty for osteoarthritis with SAIPHTM knee system by Prof Piers Yates, Prof Gareth Prosser, A/Prof Christopher Jones or Mr Peter D’Alessandro

Exclusion criteria

1) Participants with poor English who are unable to complete the questionnaires and understand instructions 2) Bilateral TKA 3) Posttraumatic OA 4) Previous HTO previous TTO +/- MPFL 5) Previous patella dislocation 6) Rheumatoid/inflammatory arthritis 7) Dementia 8) Chronic pain not related to operative knee 9) Patients with significant patella maltracking as diagnosed by the treating surgeon

Outcome results