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Effects of Surgical Timing in Staged Total Knee Arthroplasty on Pain Sensitization, Functional Outcomes, and Adverse Events: Prospective Cohort Study (STKA-PFD Study)

Effects of Surgical Timing in Staged Total Knee Arthroplasty on Pain Sensitization, Functional Outcomes, and Adverse Events: Prospective Cohort Study (STKA-PFD Study)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128497
Enrollment
Unknown
Registered
2026-07-21
Start date
2026-07-31
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis (KOA)

Interventions

Group B (with an interval of 90-180 days):None
Group C (with an interval of 180-270 days):None
Group D (with an interval of 270-360 days):None
Group E (interval>360 days):None
Group A (interval<90 days):None

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.age >=18 years, either sex, and scheduled to undergo bilateral TKA; 2.a confirmed diagnosis of primary, symptomatic bilateral knee osteoarthritis based on radiographic and clinical examinations, with fulfillment of the indications for total knee arthroplasty; 3.planned staged TKA at the same medical center, with both procedures performed by the same surgical team using the same surgical technique and prosthesis type; 4.provision of written informed consent;

Exclusion criteria

Exclusion criteria: 1.severe disorders of the spine, hip, or ankle joints; 2.inflammatory arthritis (e.g., rheumatoid arthritis), secondary arthritis (e.g., post-traumatic arthritis), or Charcot arthropathy; 3.neurologic disorders, such as diabetic peripheral neuropathy, Parkinson’s disease, and multiple sclerosis; 4.participants unable to communicate effectively because of a low educational level or language barriers; 5.a history of previous knee surgery; 6.chronic pain syndromes, including chronic headache, chronic low back pain, and fibromyalgia; 7.systemic inflammatory or autoimmune diseases, such as rheumatoid arthritis, ankylosing spondylitis, and systemic lupus erythematosus; 8.long-term use of opioids, sedative-hypnotics, or antidepressants; 9.alcohol dependence or withdrawal;

Design outcomes

Primary

MeasureTime frame
EQ-5D-3L scores 3 months after the second surgery;

Secondary

MeasureTime frame
Pain scores during resting;Basic Activities of Daily Living;neurocognitive function;Adverse events;Consumption of analgesic drugs;Instrumental Activities of Daily Living;Oxford Knee Score;pain sensitization;EQ-5D-3L scores;depressive symptoms;Pain scores during exercise;

Countries

China

Contacts

Public ContactShaoqi Tian

The Affiliated Hospital of Qingdao University

shaoqi99@aliyun.com+86 532 82919032

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026