Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT06066684

Conditions

Osteo Arthritis Knee

Chronic Post-operative Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

n/a, observational

Study Details

Brief 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. 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

Study ID

NCT06066684

Start date

Sep 18, 2023

Status verified date

Sep, 2023

Completion date

Sep 18, 2025

Anticipated

Primary completion date

Jun 18, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • adult patients aged 18 or older
  • on the waitlist for TKA (unilateral) for knee osteoarthritis

Exclusion Criteria:

  • undergoing revision or non-elective surgery
  • unable to provide informed consent and follow study procedures

Study Design

Enrollment

55 participants

Anticipated

Interventions and Outcome Measures

Interventions

n/a, observational

n/a, observational study

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 ]

Central Contacts and Locations

Central contacts

OA pain research coordinator

416-597-3422TRI-SPARC@uhn.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 6, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2023-12-06.