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A Comparison of Different Patellar Implant Designs in Total Knee Replacement.

A prospective randomized comparative trial (pilot study) to compare intra-operative and post-operative outcome measures between inset, onlay round and onlay oval designs of patellar implants in patients undergoing unilateral total knee arthroplasty for degenerative osteoarthritis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000920493
Enrollment
60
Registered
2016-07-11
Start date
2016-06-15
Completion date
2016-08-31
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Aim: To compare the intra-operative and post-operative outcome measures between three different patellar implant designs in patients undergoing total knee arthroplasty (TKA) surgery with regards to patellar bone coverage and tracking, patient-reported outcomes and post-operative radiological and scintigraphic analysis. Background: Controversy remains regarding whether the patella should be resurfaced in total knee arthroplasty. However, at present the scientific literature supports patellar resurfacing with regards to reduced re-operation risk and improved long term patient satisfaction. Two basic techniques present for resurfacing the patella; either onlay or inset. In the inset design, a round domed implant is reamed in the patella and fixed with a single central projection (peg). On the other hand, the onlay design has either round (symmetrical) or oval (asymmetrical) shaped patellae with three small peripheral pegs fixed on the cut surface of the patella. When using a round patellar implant, either onlay or inset, some surgeons perform a lateral facetectomy to avoid lateral compression syndrome and enhance patellar tracking. However, neither method has proved to be superior. A wide range of complications are associated with patellar resurfacing. These include patellar fracture, osteonecrosis related to devascularisation, patellar polyethylene (PE) wear, aseptic loosening, instability, dislocation, overstuffing and rupture of the extensor mechanism. Many of these can be catastrophic. One should always consider the peculiar blood supply to the patella during TKA and patellar resurfacing as iatrogenic disruption of supplying vessels has been identified as a major contributing factor in post-operative patellofemoral complications. The hypothesis of this study is that onlay oval design provides optimal bone coverage, better tracking, better patient reported outcome scores and carries the lowest risk of osteonecrosis in comparison with the other two designs. Trial Objectives: To prospectively compare intra-operative observed measures, patient-reported outcome measures and radiological results between inset, onlay round and onlay oval designs of patellar implants in patients undergoing total knee arthroplasty surgery. Specifically, we will compare patellar surface bone coverage, pain and functional scores together with patellar tracking and vascular status of the patella postoperatively.

Interventions

This research will study the outcomes of using different patellar implants in Total Knee Arthroplasty (TKA). Patients with knee osteoarthritis undergoing TKA will be randomized into three groups allocated to one of the three patellar implants' designs. The different patellar designs to be evaluated in this study are: - Onlay oval: asymmetrical oval patella designs with three projections cemented on the resurfaced patella. - Onlay round: symmetrical round patella designs with three projections c

This research will study the outcomes of using different patellar implants in Total Knee Arthroplasty (TKA). Patients with knee osteoarthritis undergoing TKA will be randomized into three groups allocated to one of the three patellar implants' designs. The different patellar designs to be evaluated in this study are: - Onlay oval: asymmetrical oval patella designs with three projections cemented on the resurfaced patella. - Onlay round: symmetrical round patella designs with three projections cemented on the resurfaced patella. - Inset: a round biconvex design with one projection cemented on reamed under-surface of patella. Intervention will be performed by a fellowship trained surgeons with minimum 10 years experience. The approximate duration of the TKA procedure is around 90 minutes. The duration of performing the selected patellar implants is 5-10 minutes. Adherence to the assigned randomization will be monitored by the assisting fellow. any misconduct or fidelity will be documented and reported in the monthly research meeting.

Sponsors

Sydney Knee Specialist
Lead SponsorCommercial sector/Industry

Study design

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

Eligibility

Sex/Gender
All
Age
50 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

Patients undergoing unilateral total knee arthroplasty for degenerative osteoarthritis

Exclusion criteria

- Revision TKA surgery - Bilateral simultaneous TKA - Prior osteotomies around the knee or extra-articular deformities - Systemic inflammatory disease (e.g. rheumatoid arthritis, Systemic lupus erythematosus, etc) - Medial and lateral knee ligamentous instability on knee examination. - TKA for acute trauma and need for allograft - Prior patellar fracture, ruptured extensor mechanism - Constrained implants, stemmed components or metal augmentation during surgery.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026