- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05367375
Comparison of Removing and Non-removing Patellofemoral Joint Osteophytes Following Medial Unicompartment Knee Arthroplasty
Does Removing Patellofemoral Joint Osteophytes Reduce Anterior Knee Pain Following Unicompartment Knee Arthroplasty?
Background: Anterior knee pain (AKP) is a challenge following unicompartmental knee arthroplasty (UKA). Some surgeons remove patellofemoral joint (PFJ) osteophytes to reduce osteophyte impingement and AKP. However, there is evidence that PFJ osteophytes compensate for knee osteoarthritis (OA) by increasing and improving stability and increase contract surface area in knee osteoarthritis. Moreover, when PFJ osteophytes are not removed, some studies report good clinical outcomes. The issue of removing or leaving PFJ osteophytes is controversial.
The objective of this study was to compare AKP following mobile bearing UKA after removing or leaving PFJ osteophytes.
Methods: The prospective non-randomized study included 89 isolated medial osteoarthritis (OA) of knee. They were classified into 2 groups. Group (Gp)1 was removing PFJ osteophytes; consists of 44 knees. Gp2 was non-removing PFJ osteophytes: consists of 45 knees. The patients were follow up and recorded incidence of AKP and VAS for AKP at 6 weeks, 3months, 6 months, 1 year and 2 years. No patients were lost to follow up. The patellar tilt and shift were measured at 6 weeks, 3months, 6months, 1year and 2 years via skyline view radiography. The knee society scores, Oxford knee score, knee injury and osteoarthritis outcome score, forgotten joint score and Kujala scale also were recorede at 6 weeks, 3months, 6months, 1 year and 2 years.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age > 42 years old
- range of motion > 90 degrees
- flexion contracture< 15 degrees
- normal function of anterior cruciate ligament
Exclusion Criteria:
- spontaneous osteonecrosis of the knee
- inflammatory joinr arthritis
- full thickness cartilage loss at lateral compartment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
removing patellofemoral joint osteophytes
remove osteophyte at patella, medial femoral condyle and lateral femoral condyle
|
to compare anterior knee pain between removing patellofemoral joint osteophytes and non-removing patellofemoral joint osteophytes after medial unicompartmental knee arthroplasty
|
|
non-removing patellofemoral joint osteophytes
no remove osteophyte at patella, medial femoral condyle and lateral femoral condyle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
incidence of anterior knee pain
Time Frame: 6 weeks
|
number of participant that had anterior knee pain
|
6 weeks
|
|
incidence of anterior knee pain
Time Frame: 3 months
|
number of participant that had anterior knee pain
|
3 months
|
|
incidence of anterior knee pain
Time Frame: 6 months
|
number of participant that had anterior knee pain
|
6 months
|
|
incidence of anterior knee pain
Time Frame: 1 year
|
number of participant that had anterior knee pain
|
1 year
|
|
incidence of anterior knee pain
Time Frame: 2 year
|
number of participant that had anterior knee pain
|
2 year
|
|
Visual analogue scale for anterior knee pain
Time Frame: 6 weeks
|
pain score 0= no pain and pain score 10= maximum pain
|
6 weeks
|
|
Visual analogue scale for anterior knee pain
Time Frame: 3 months
|
pain score 0= no pain and pain score 10= maximum pain
|
3 months
|
|
Visual analogue scale for anterior knee pain
Time Frame: 6 months
|
pain score 0= no pain and pain score 10= maximum pain
|
6 months
|
|
Visual analogue scale for anterior knee pain
Time Frame: 1 year
|
pain score 0= no pain and pain score 10= maximum pain
|
1 year
|
|
Visual analogue scale for anterior knee pain
Time Frame: 2 years
|
pain score 0= no pain and pain score 10= maximum pain
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MTU-EC-OT-0-224/62
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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