Osteo Arthritis KneeNCT06066684
Pain Phenotyping in Knee OA: a Pilot Trial
An observational study of Osteo Arthritis Knee and Chronic Post-operative Pain, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
Osteoarthritis (OA) is disease in which the joint breaks down, causing pain. The decision to surgically replace the knee, a procedure called total knee arthroplasty (TKA), depends on x-ray results as well as pain and dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis Knee, Chronic Post-operative Pain
- What is being tested?
- n/a, observational
- How many people
- 55 participants
- Where
- 2 sitesCanada
- Study dates
- 18 Sep 2023to 18 Sep 2025
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: adult knee osteoarthritis patients
Who may be able to join
- adult patients aged 18 or older
- on the waitlist for TKA (unilateral) for knee osteoarthritis
Who cannot join
- undergoing revision or non-elective surgery
- unable to provide informed consent and follow study procedures
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Not yet recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
TRI-SPARC@uhn.ca
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
TRI-SPARC@uhn.ca
About this study
Official title: Prediction Modelling of TKA Non-responders Using Clinical and Pain Sensitization Measures
Osteoarthritis (OA) is disease in which the joint breaks down, causing pain. The decision to surgically replace the knee, a procedure called total knee arthroplasty (TKA), depends on x-ray results as well as pain and dysfunction. Despite TKA resulting in good outcomes for most patients, between 1 in 10 and 1 in 5 patients remain in significant pain - i.e., are 'TKA non-responders'. Two pain conditions - myofascial pain syndrome (MPS) and central sensitization - frequently coexist with signs of OA and may contribute to a TKA non-responder profile. MPS, caused by knots within skeletal muscle, can contribute to an OA patient's pain and dysfunction. In central sensitization, faulty pain sensing leads to increased pain sensitivity. However, there is currently no established process to identify these sources of pain and potential associated TKA non-responder risk. Our research aims conduct a pilot study to examine the impact of pain diagnosis tools to help orthopedic surgeons identify potential TKA nonresponders. This new approach may increase healthcare efficiency (reduce TKA waitlist and length of hospital stay), and help patients receive the right care at the right time.
- Conditions
- Osteo Arthritis Knee, Chronic Post-operative Pain
- Being tested
- n/a, observational
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n/a, observationalOther
n/a, observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical prediction model feasibility as determined by: Recruitment rate, follow-up at 12 months post-op, multivariable logistic regression
Measured: 21 months
Secondary outcomes (7)
Pain regions and pain pattern, as assessed by Pain Body Diagram
Measured: 21 months
Likelihood of neuropathic pain component, as assessed by the painDETECT questionnaire
Measured: 21 months
Symptoms of central sensitisation, as assessed by the Central Sensitization Inventory questionnaire
Measured: 21 months
Physical function, as assessed by the Aggregate Locomotor Function test
Measured: 21 months
Prevalence of myofascial trigger points
Measured: 21 months
Pain facilitation, as assessed by Temporal Summation of Pain (wind-up)
Measured: 21 months
Deep tissue pain sensitivity, as assessed by Pain Pressure Threshold
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start18 Sep 2023
- Primary completion18 Jun 2025 (estimated)
- Study completion18 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dinesh Kumbhare, MD, PhD, Principal investigator, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066684
- Sponsor's protocol ID
- CTO3624
- Status last verified
- Sep 2023
- First submitted
- 27 Sep 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Modelling of TKA Non-responders Using Clinical and Pain Sensitization Measures
- ClinicalTrials.gov ID
- NCT06066684
- Acronym / sponsor ID
- CTO3624
- Conditions
- Osteo Arthritis Knee, Chronic Post-operative Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 18 Jun 2025 (estimated)
- Study completion
- 18 Sep 2025 (estimated)
- First posted
- 4 Oct 2023 (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.
Osteoarthritis (OA) is disease in which the joint breaks down, causing pain. The decision to surgically replace the knee, a procedure called total knee arthroplasty (TKA), depends on x-ray results as well as pain and dysfunction. Despite TKA resulting in good outcomes for most patients, between 1 in 10 and 1 in 5 patients remain in significant pain - i.e., are 'TKA non-responders'. Two pain conditions - myofascial pain syndrome (MPS) and central sensitization - frequently coexist with signs of OA and may contribute to a TKA non-responder profile. MPS, caused by knots within skeletal muscle, can contribute to an OA patient's pain and dysfunction. In central sensitization, faulty pain sensing leads to increased pain sensitivity. However, there is currently no established process to identify these sources of pain and potential associated TKA non-responder risk. Our research aims conduct a pilot study to examine the impact of pain diagnosis tools to help orthopedic surgeons identify potential TKA nonresponders. This new approach may increase healthcare efficiency (reduce TKA waitlist and length of hospital stay), and help patients receive the right care at the right time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult knee osteoarthritis patients
Key inclusion criteria (2 listed)
- adult patients aged 18 or older
- on the waitlist for TKA (unilateral) for knee osteoarthritis
Key exclusion criteria (2 listed)
- undergoing revision or non-elective surgery
- unable to provide informed consent and follow study procedures
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 |
|---|---|---|
| n/a, observationaln/a, observational study | Other | – |
Primary outcome
Clinical prediction model feasibility as determined by: Recruitment rate, follow-up at 12 months post-op, multivariable logistic regression
Time frame: 21 months
7 secondary outcomes
Pain regions and pain pattern, as assessed by Pain Body Diagram
Time frame: 21 months
Likelihood of neuropathic pain component, as assessed by the painDETECT questionnaire
Time frame: 21 months
Symptoms of central sensitisation, as assessed by the Central Sensitization Inventory questionnaire
Time frame: 21 months
Physical function, as assessed by the Aggregate Locomotor Function test
Time frame: 21 months
Prevalence of myofascial trigger points
Time frame: 21 months
Pain facilitation, as assessed by Temporal Summation of Pain (wind-up)
Time frame: 21 months
Deep tissue pain sensitivity, as assessed by Pain Pressure Threshold
Time frame: 21 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
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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.
Dinesh Kumbhare, MD, PhD principal investigator
UHN
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteo Arthritis Knee and Chronic Post-operative Pain, run by University Health Network, Toronto at 2 sites in Canada.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact OA pain research coordinator (416-597-3422 ext. 3115, TRI-SPARC@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical prediction model feasibility as determined by: Recruitment rate, follow-up at 12 months post-op, multivariable logistic regression (time frame: 21 months). 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 6 Dec 2023.