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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05367375
Other study ID # MTU-EC-OT-0-224/62
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date November 1, 2021

Study information

Verified date May 2022
Source Thammasat University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Removing and non-removing osteophyte at patellofemoral joint is controversial topic. The osteophyte may help to reduce load and improve stability of patellofemoral joint. Therefore, the purpose of this study is to compared anterior knee pain between removing and non-removing osteophyte at patellofemoral joint following medial mobile bearing unicompartmental knee arthroplasty


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date November 1, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers No
Gender All
Age group 43 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Thammasat University

Outcome

Type Measure Description Time frame Safety issue
Primary incidence of anterior knee pain number of participant that had anterior knee pain 6 weeks
Primary incidence of anterior knee pain number of participant that had anterior knee pain 3 months
Primary incidence of anterior knee pain number of participant that had anterior knee pain 6 months
Primary incidence of anterior knee pain number of participant that had anterior knee pain 1 year
Primary incidence of anterior knee pain number of participant that had anterior knee pain 2 year
Primary Visual analogue scale for anterior knee pain pain score 0= no pain and pain score 10= maximum pain 6 weeks
Primary Visual analogue scale for anterior knee pain pain score 0= no pain and pain score 10= maximum pain 3 months
Primary Visual analogue scale for anterior knee pain pain score 0= no pain and pain score 10= maximum pain 6 months
Primary Visual analogue scale for anterior knee pain pain score 0= no pain and pain score 10= maximum pain 1 year
Primary Visual analogue scale for anterior knee pain pain score 0= no pain and pain score 10= maximum pain 2 years
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