Determining the Minimum Clinically Important Difference (MCID) and Patient Acceptable Symptom State (PASS) for Acute Pain and Quality of Recovery After Orthopedic Surgery

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

This study seeks to define what constitutes an MCID and a PASS in patients undergoing a variety of elective major orthopedic surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
View:

• Adult patients aged 18-80 years

• ASA class I - III

• Primary elective surgery

• unilateral major shoulder surgery e.g., stabilization and arthroplasty procedures:

• unilateral total hip replacement

• unilateral total knee replacement, and

• spinal decompression + fusion involving ≥ 2 levels.

• Hospital admission for ≥ 24 hours after the surgery

Locations
Other Locations
Canada
Toronto Western Hopspital
RECRUITING
Toronto
Contact Information
Primary
Jayanta Chowdhury, MBBS,MD
jayanta.chowdhury@uhn.ca
4166035800
Backup
Anahi Perlas, MD, FRCPC
Time Frame
Start Date: 2021-06-21
Estimated Completion Date: 2024-11-07
Participants
Target number of participants: 300
Treatments
single group, open labelled observational study with no blinding.
All study patients will be managed per routine clinical practice and institutional standard for the performed surgery.
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov