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| Name | Class |
|---|---|
| Stryker Nordic | INDUSTRY |
| DePuy Orthopaedics | INDUSTRY |
| Rigshospitalet, Denmark | OTHER |
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This is a randomized comparison of PFA and TKR in treatment of isolated patellofemoral osteoarthritis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avon patellofemoral replacement | Experimental | Knee arthroplasty with insertion of patellofemoral joint replacement. |
|
| PFC Sigma CR total knee replacement | Active Comparator | Knee arthroplasty with total (tricompartmental) knee replacement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Knee arthroplasty | Device | Comparison of patellofemoral arthroplasty versus conventional total knee arthroplasty in cases of isolated patellofemoral osteoarthritis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported outcomes (disease-specific and generic QoL instruments) | 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). | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Implant survival, clinician assessment and cost. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Odgaard, FRCS, DMSc | Dept. of Orthopaedics, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41248881 | Result | Martinique VB, Julie H, Snorre S, Soeren R, Kristensen WP, Zahid A, Alex L, Justin C, Anders O. Equivocal physical activity outcomes 10 Years after patellofemoral vs total knee replacement: Follow-up of a previously reported randomized controlled trial in isolated patellofemoral joint osteoarthritis. J ISAKOS. 2026 Apr;17:101037. doi: 10.1016/j.jisako.2025.101037. Epub 2025 Nov 15. | |
| 37352486 |
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IPD that underlie the results reported in published article, after deidentification (text, tables, figures and appendices).
Beginning 6 months and and ending 5 years following article publication.
For investigators whose proposed use of the data has been approved by and independent review committee identified for this purpose or for researchers who provide a methdologically sound proposal.
Types of analyses accepted: For acheiving aims of the approved proposal.
Proposals should be directed to anders.odgaard@regionh.dk. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years following publication at a third party website.
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| D000092462 | Patella Fracture |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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Pragmatic, multi-centre, 1:1 parallel-group, randomised controlled trial. Double-blinded for 1st year. PROMs completion without staff involvement. Statistical consultants blinded.
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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.
|
| 10 years |
| Result |
| Odgaard A, Kappel A, Madsen F, Kristensen PW, Stephensen S, Attarzadeh AP. Erratum to: Patellofemoral Arthroplasty Results in Better Time-weighted Patient-reported Outcomes After 6 Years than TKA: A Randomized Controlled Trial. Clin Orthop Relat Res. 2023 Jul 1;481(7):1455-1457. doi: 10.1097/CORR.0000000000002713. Epub 2023 Jun 15. No abstract available. |
| 35315804 | Result | Odgaard A, Kappel A, Madsen F, Kristensen PW, Stephensen S, Attarzadeh AP. Patellofemoral Arthroplasty Results in Better Time-weighted Patient-reported Outcomes After 6 Years than TKA: A Randomized Controlled Trial. Clin Orthop Relat Res. 2022 Sep 1;480(9):1707-1718. doi: 10.1097/CORR.0000000000002178. Epub 2022 Mar 21. |
| 32228074 | Result | Fredborg C, Odgaard A, Sorensen J. Patellofemoral arthroplasty is cheaper and more effective in the short term than total knee arthroplasty for isolated patellofemoral osteoarthritis: cost-effectiveness analysis based on a randomized trial. Bone Joint J. 2020 Apr;102-B(4):449-457. doi: 10.1302/0301-620X.102B4.BJJ-2018-1580.R3. |
| 29529622 | Result | Odgaard A, Madsen F, Kristensen PW, Kappel A, Fabrin J. The Mark Coventry Award: Patellofemoral Arthroplasty Results in Better Range of Movement and Early Patient-reported Outcomes Than TKA. Clin Orthop Relat Res. 2018 Jan;476(1):87-100. doi: 10.1007/s11999.0000000000000017. |
| D000092443 |
| Knee Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |