Study of Knee Replacements for Patellofemoral Osteoarthritis (PFA/TKR)
Primary Purpose
Osteoarthritis, Knee
Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Knee arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee, Knee cap, Patella, Patellofemoral
Eligibility Criteria
Inclusion Criteria:
- Isolated PF-OA
Exclusion Criteria:
- Medial or lateral OA
Sites / Locations
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Avon patellofemoral replacement
PFC Sigma CR total knee replacement
Arm Description
Knee arthroplasty with insertion of patellofemoral joint replacement.
Knee arthroplasty with total (tricompartmental) knee replacement.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01326156
First Posted
May 19, 2009
Last Updated
November 4, 2020
Sponsor
University of Aarhus
Collaborators
Stryker Nordic, DePuy Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT01326156
Brief Title
Study of Knee Replacements for Patellofemoral Osteoarthritis
Acronym
PFA/TKR
Official Title
Patellofemoral Arthroplasty (PFA) Versus Total Knee Replacement (TKR) for Isolated Patellofemoral Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2007 (Actual)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Stryker Nordic, DePuy Orthopaedics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, Knee, Knee cap, Patella, Patellofemoral
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Avon patellofemoral replacement
Arm Type
Experimental
Arm Description
Knee arthroplasty with insertion of patellofemoral joint replacement.
Arm Title
PFC Sigma CR total knee replacement
Arm Type
Active Comparator
Arm Description
Knee arthroplasty with total (tricompartmental) knee replacement.
Intervention Type
Device
Intervention Name(s)
Knee arthroplasty
Other Intervention Name(s)
PFA: Avon Patellofemoal arthroplasty (Stryker), TKR: PFC Sigma CR arthroplasty (DePuy)
Intervention Description
Comparison of patellofemoral arthroplasty versus conventional total knee arthroplasty in cases of isolated patellofemoral osteoarthritis.
Primary Outcome Measure Information:
Title
Patient-reported outcomes (disease-specific and generic QoL instruments)
Description
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).
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Implant survival, clinician assessment and cost.
Description
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.
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Isolated PF-OA
Exclusion Criteria:
Medial or lateral OA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Odgaard, FRCS, DMSc
Organizational Affiliation
Dept. of Orthopaedics, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD that underlie the results reported in published article, after deidentification (text, tables, figures and appendices).
IPD Sharing Time Frame
Beginning 6 months and and ending 5 years following article publication.
IPD Sharing Access Criteria
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.
Citations:
PubMed Identifier
35315804
Citation
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. Erratum In: Clin Orthop Relat Res. 2023 Jul 1;481(7):1455-1457.
Results Reference
derived
Learn more about this trial
Study of Knee Replacements for Patellofemoral Osteoarthritis
We'll reach out to this number within 24 hrs