Osteoarthritis, KneeNCT03676179
The Comparison of Anterior Knee Pain in Patella With or Without Denervation in Medial Unicompartmental Knee Arthroplasty
A study testing patella denervation and patella non-denervation in people with Osteoarthritis, Knee, run by Ramathibodi Hospital at 1 site in Thailand.
Trial summary
the present study will conduct to assess anterior knee pain and complications after medial UKA with or without patella denervation in medial compartment arthritis and severe lateral facet patellofemoral arthritis patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- patella denervation and patella non-denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2018to 1 Apr 2019
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who diagnose with medial osteoarthritis (OA) of the knee with an Alhback score of 2, 3 and 4 (Ahlback 1968) and with any Kujala score for pre-operative anterior knee pain.
- Older than 40 years of age.
- pain on the medial joint line.
- primary medial compartment osteoarthritis with a well preserved lateral compartment with competent cruciate ligaments with correctable intraarticular varus deformity.
- ROM flexion up to 110° under anesthesia.
Who cannot join
- Patients with fixed varus deformity > 15°
- Inflammatory arthritis
- Previous high tibial osteotomy or ACL reconstruction
Trial locations and contacts
1 site in 1 country.
About this study
the present study will conduct to assess anterior knee pain and complications after medial UKA with or without patella denervation in medial compartment arthritis and severe lateral facet patellofemoral arthritis patients.
Read the detailed description
In this prospective cohort study, the investigators will conduct to compare the clinical result of 70 patients of unicompartment knee arthroplasty with and without patella denervation between April, 2018 and April, 2019 for the patients with osteoarthritis.
- Conditions
- Osteoarthritis, Knee
- Being tested
- patella denervation, patella non-denervation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patella denervationProcedure or surgery
patella denervation
patella non-denervationProcedure or surgery
patella non-denervation
| Study group | Role | What they receive |
|---|---|---|
| unicompartment knee arthroplasty and patella denervation | Active comparator | UKA and patella denervation Receives: Procedure: patella denervation |
| unicompartment knee arthroplasty and patella non-denervation | Experimental | UKA and patella non-denervation Receives: Procedure: patella non-denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kujala score
Kujala score including 13 parameters with the score of 0-100, the higher the score the better the function.
Measured: 6 months
Secondary outcomes (1)
complication
number of participant with DVT, infections, loosening of implants, fractures, lateral compartment arthritis, and dislocations of the polyethylene
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 Mar 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- unicompartment knee arthroplasty with patella denervation
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pranungkraw General Hospital
- Responsible party
- Principal investigator, Jatupon Kongtharvonskul, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676179
- Sponsor's protocol ID
- 08/2561
- Status last verified
- Mar 2019
- First submitted
- 16 Sep 2018
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Suwankomonkul P, Arirachakaran A, Kongtharvonskul J. Short-term improvement of patellofemoral pain in medial unicompartmental knee arthroplasty with patellar denervation: a prospective comparative study. Musculoskelet Surg. 2022 Mar;106(1):75-82. doi: 10.1007/s12306-020-00675-7. Epub 2020 Aug 2.
PubMed 32743756
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Anterior Knee Pain in Patella With or Without Denervation in Medial Unicompartmental Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03676179
- Acronym / sponsor ID
- 08/2561
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Collaborators
- Pranungkraw General Hospital
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 18 Sep 2018 (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.
the present study will conduct to assess anterior knee pain and complications after medial UKA with or without patella denervation in medial compartment arthritis and severe lateral facet patellofemoral arthritis patients.
Detailed description
In this prospective cohort study, the investigators will conduct to compare the clinical result of 70 patients of unicompartment knee arthroplasty with and without patella denervation between April, 2018 and April, 2019 for the patients with osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- unicompartment knee arthroplasty with patella denervation
| Arm | Type | Receives |
|---|---|---|
| unicompartment knee arthroplasty and patella denervation | Active comparator | Procedure: patella denervationUKA and patella denervation |
| unicompartment knee arthroplasty and patella non-denervation | Experimental | Procedure: patella non-denervationUKA and patella non-denervation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who diagnose with medial osteoarthritis (OA) of the knee with an Alhback score of 2, 3 and 4 (Ahlback 1968) and with any Kujala score for pre-operative anterior knee pain.
- Older than 40 years of age.
- pain on the medial joint line.
- primary medial compartment osteoarthritis with a well preserved lateral compartment with competent cruciate ligaments with correctable intraarticular varus deformity.
- ROM flexion up to 110° under anesthesia.
Key exclusion criteria (3 listed)
- Patients with fixed varus deformity > 15°
- Inflammatory arthritis
- Previous high tibial osteotomy or ACL reconstruction
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 |
|---|---|---|
| patella denervationpatella denervation | Procedure or surgery | unicompartment knee arthroplasty and patella denervation |
| patella non-denervationpatella non-denervation | Procedure or surgery | unicompartment knee arthroplasty and patella non-denervation |
Primary outcome
Kujala score
Time frame: 6 months
Kujala score including 13 parameters with the score of 0-100, the higher the score the better the function.
1 secondary outcome
complication
Time frame: 6 months
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 2 Apr 2019.
- Derived from this study: PubMed 32743756Suwankomonkul P, Arirachakaran A, Kongtharvonskul J. Short-term improvement of patellofemoral pain in medial unicompartmental knee arthroplasty with patellar denervation: a prospective comparative study. Musculoskelet Surg. 2022 Mar;106(1):75-82. doi: 10.1007/s12306-020-00675-7. Epub 2020 Aug 2.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patella denervation and patella non-denervation in people with Osteoarthritis, Knee, run by Ramathibodi Hospital at 1 site in Thailand.
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 5 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 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Kujala score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03676179, which also lists 1 linked publication.
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 2 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.