NCT05367375

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

4.3 years

First QC Date

May 1, 2022

Last Update Submit

May 4, 2022

Conditions

Anterior Knee Pain

Keywords

patellofemoral osteophyteanteromedial osteoarthritis kneemobile bearing UKApatellofemoral pain

Outcome Measures

Primary Outcomes (10)

  • incidence of anterior knee pain

    number of participant that had anterior knee pain

    6 weeks

  • incidence of anterior knee pain

    number of participant that had anterior knee pain

    3 months

  • incidence of anterior knee pain

    number of participant that had anterior knee pain

    6 months

  • incidence of anterior knee pain

    number of participant that had anterior knee pain

    1 year

  • incidence of anterior knee pain

    number of participant that had anterior knee pain

    2 year

  • Visual analogue scale for anterior knee pain

    pain score 0= no pain and pain score 10= maximum pain

    6 weeks

  • Visual analogue scale for anterior knee pain

    pain score 0= no pain and pain score 10= maximum pain

    3 months

  • Visual analogue scale for anterior knee pain

    pain score 0= no pain and pain score 10= maximum pain

    6 months

  • Visual analogue scale for anterior knee pain

    pain score 0= no pain and pain score 10= maximum pain

    1 year

  • Visual analogue scale for anterior knee pain

    pain score 0= no pain and pain score 10= maximum pain

    2 years

Study Arms (2)

removing patellofemoral joint osteophytes

remove osteophyte at patella, medial femoral condyle and lateral femoral condyle

Procedure: removing osteophyte at patellofemoral joint

non-removing patellofemoral joint osteophytes

no remove osteophyte at patella, medial femoral condyle and lateral femoral condyle

Interventions

removing osteophyte at patellofemoral jointPROCEDURE

to compare anterior knee pain between removing patellofemoral joint osteophytes and non-removing patellofemoral joint osteophytes after medial unicompartmental knee arthroplasty

removing patellofemoral joint osteophytes

Eligibility Criteria

Age43 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

isolated medial osteoarthritis of the knee

You may qualify if:

  • age \> 42 years old
  • range of motion \> 90 degrees
  • flexion contracture\< 15 degrees
  • normal function of anterior cruciate ligament

You may not qualify if:

  • spontaneous osteonecrosis of the knee
  • inflammatory joinr arthritis
  • full thickness cartilage loss at lateral compartment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

May 1, 2022

First Posted

May 10, 2022

Study Start

January 1, 2017

Primary Completion

May 1, 2021

Study Completion

November 1, 2021

Last Updated

May 10, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share