Anterior Knee PainNCT05367375
Comparison of Removing and Non-removing Patellofemoral Joint Osteophytes Following Medial Unicompartment Knee Arthroplasty
An observational study of Anterior Knee Pain, run by Thammasat University.
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. Read more about this study
- Who is it for?
- Ages 43 to 80 years
- Conditions the study is for
- Anterior Knee Pain
- What is being tested?
- removing osteophyte at patellofemoral joint
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 43 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: isolated medial osteoarthritis of the knee
Who may be able to join
- age > 42 years old
- range of motion > 90 degrees
- flexion contracture< 15 degrees
- normal function of anterior cruciate ligament
Who cannot join
- spontaneous osteonecrosis of the knee
- inflammatory joinr arthritis
- full thickness cartilage loss at lateral compartment
About this study
Official title: 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.
Read the detailed 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
- Conditions
- Anterior Knee Pain
- Being tested
- removing osteophyte at patellofemoral joint
- Keywords
- patellofemoral osteophyte, anteromedial osteoarthritis knee, mobile bearing UKA, patellofemoral pain
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
removing osteophyte at patellofemoral jointProcedure or surgery
to compare anterior knee pain between removing patellofemoral joint osteophytes and non-removing patellofemoral joint osteophytes after medial unicompartmental knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| removing patellofemoral joint osteophytes | remove osteophyte at patella, medial femoral condyle and lateral femoral condyle Receives: Procedure: removing osteophyte at patellofemoral joint | |
| non-removing patellofemoral joint osteophytes | no remove osteophyte at patella, medial femoral condyle and lateral femoral condyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of anterior knee pain
number of participant that had anterior knee pain
Measured: 6 weeks
incidence of anterior knee pain
number of participant that had anterior knee pain
Measured: 3 months
incidence of anterior knee pain
number of participant that had anterior knee pain
Measured: 6 months
incidence of anterior knee pain
number of participant that had anterior knee pain
Measured: 1 year
incidence of anterior knee pain
number of participant that had anterior knee pain
Measured: 2 year
Visual analogue scale for anterior knee pain
pain score 0= no pain and pain score 10= maximum pain
Measured: 6 weeks
Visual analogue scale for anterior knee pain
pain score 0= no pain and pain score 10= maximum pain
Measured: 3 months
Visual analogue scale for anterior knee pain
pain score 0= no pain and pain score 10= maximum pain
Measured: 6 months
Visual analogue scale for anterior knee pain
pain score 0= no pain and pain score 10= maximum pain
Measured: 1 year
Visual analogue scale for anterior knee pain
pain score 0= no pain and pain score 10= maximum pain
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 Jan 2017
- Primary completion1 May 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Knee PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boonchana Pongcharoen, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367375
- Sponsor's protocol ID
- MTU-EC-OT-0-224/62
- Status last verified
- May 2022
- First submitted
- 1 May 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Removing Patellofemoral Joint Osteophytes Reduce Anterior Knee Pain Following Unicompartment Knee Arthroplasty?
- ClinicalTrials.gov ID
- NCT05367375
- Acronym / sponsor ID
- MTU-EC-OT-0-224/62
- Conditions
- Anterior Knee Pain
- Keywords
- patellofemoral osteophyte, anteromedial osteoarthritis knee, mobile bearing UKA, patellofemoral pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| removing patellofemoral joint osteophytes | – | Procedure: removing osteophyte at patellofemoral jointremove osteophyte at patella, medial femoral condyle and lateral femoral condyle |
| non-removing patellofemoral joint osteophytes | – | –no remove osteophyte at patella, medial femoral condyle and lateral femoral condyle |
Who may qualify
- Ages
- 43 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- isolated medial osteoarthritis of the knee
Key inclusion criteria (4 listed)
- age > 42 years old
- range of motion > 90 degrees
- flexion contracture< 15 degrees
- normal function of anterior cruciate ligament
Key exclusion criteria (3 listed)
- spontaneous osteonecrosis of the knee
- inflammatory joinr arthritis
- full thickness cartilage loss at lateral compartment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| removing osteophyte at patellofemoral jointto compare anterior knee pain between removing patellofemoral joint osteophytes and non-removing patellofemoral joint osteophytes after medial unicompartmental knee arthroplasty | Procedure or surgery | removing patellofemoral joint osteophytes |
Primary outcome
incidence of anterior knee pain
Time frame: 6 weeks
number of participant that had anterior knee pain
incidence of anterior knee pain
Time frame: 3 months
number of participant that had anterior knee pain
incidence of anterior knee pain
Time frame: 6 months
number of participant that had anterior knee pain
incidence of anterior knee pain
Time frame: 1 year
number of participant that had anterior knee pain
incidence of anterior knee pain
Time frame: 2 year
number of participant that had anterior knee pain
Visual analogue scale for anterior knee pain
Time frame: 6 weeks
pain score 0= no pain and pain score 10= maximum pain
Visual analogue scale for anterior knee pain
Time frame: 3 months
pain score 0= no pain and pain score 10= maximum pain
Visual analogue scale for anterior knee pain
Time frame: 6 months
pain score 0= no pain and pain score 10= maximum pain
Visual analogue scale for anterior knee pain
Time frame: 1 year
pain score 0= no pain and pain score 10= maximum pain
Visual analogue scale for anterior knee pain
Time frame: 2 years
pain score 0= no pain and pain score 10= maximum pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No
Related trials for Anterior Knee Pain
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Postoperative Pain, Knee Arthroscopy
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Geko™ Device in Prevention of Pain and Swelling Following Knee Arthroscopy
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Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Knee Pain, run by Thammasat University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of anterior knee pain (time frame: 6 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.