Osteoarthritis, Knee, Patellofemoral Knee Arthroplasty
Conditions
Keywords
Osteoarthritis, Knee, Knee cap, Patella, Patellofemoral
Brief summary
This is a randomized comparison of PFA and TKR in treatment of isolated patellofemoral osteoarthritis.
Detailed description
Isolated patellofemoral osteoarthritis can be a disabling condition of the knee necessitating knee arthroplasty. It is debated whether total knee replacement or isolated patellofemoral replacement is the better treatment option. This randomized trial attempts to give a qualified answer to the debate by comparing clinical outcome (range of movement, stability, effusion, patellofemoral tracking, tenderness, stair climbing), patient self assessment scores (EQ-5D, Oxford Knee Score, KOOS, SF-36, AKS), complications (infections, revisions), longevity (survival analysis) and cost (direct and indirect) for the two implant types. The Avon patellofemoral implant has been chosen, as this is the patellofemoral implant with the best documentation. The PFC Sigma CR total knee implant has been chosen as it a current standard implant and market leader.
Interventions
DEVICEKnee arthroplasty
Comparison of patellofemoral arthroplasty versus conventional total knee arthroplasty in cases of isolated patellofemoral osteoarthritis.
Sponsors
Stryker Nordic
DePuy Orthopaedics
Rigshospitalet, Denmark
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Patients are blinded to treatment allocation for the first year; they are un-blinded at the one-year follow-up. Hospital staff, excluding the surgical team, are likewise blinded. Discharge letters are intended to exclude implant information to ensure general practitioner blinding.
Intervention model description
Pragmatic, multi-centre, 1:1 parallel-group, randomised controlled trial. Double-blinded for 1st year. PROMs completion without staff involvement. Statistical consultants blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Isolated PF-OA
Exclusion criteria
* Medial or lateral OA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported outcomes (disease-specific and generic QoL instruments) | 10 years | The physical functioning score of the Short Form (36) Health Survey is the primary outcome measure of the study. Disease-specific patient-reported outcomes (Oxford Knee Score, KOOS and Kujala) and a second generic quality of life measure (EQ5D). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant survival, clinician assessment and cost. | 10 years | Secondary outcome measures relate to implant survival, clinician assessment and cost. Implant survival will be assessed by 5- and 10-year implant survival rates and by analyzing causes for revision surgery. Clinician assessment includes Knee Society Score (stability, range of movement, effusion, tenderness etc.). Assessments of immediate and long-term costs are based on patient diaries, sick leave, use of medical services and drug prescriptions. |
Countries
Denmark
Outcome results
None listed