Comparing fast track and standard care for total knee replacement
Randomised Controlled Study Comparing Fast Track and Standard Care Protocol on the Functional Outcomes and Hospital Stay of Total Knee Arthroplasty
This study is testing if a quicker recovery plan for knee replacement surgery helps patients feel better and recover faster compared to the usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 78 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT03869996 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a fast track protocol for total knee arthroplasty (TKA) compared to standard care. The fast track approach includes preoperative education, oral pain management, and early rehabilitation on the day of surgery, while standard care involves intravenous pain management and physiotherapy starting the day after surgery. The study will assess functional and subjective outcomes, hospital stay duration, transfusion needs, and analgesic consumption between the two groups. By optimizing the recovery process, the study seeks to enhance patient outcomes following knee surgery.
Who should consider this trial
Good fit: Ideal candidates are patients with knee osteoarthritis who are eligible for primary total knee arthroplasty and meet specific health criteria.
Not a fit: Patients with psychiatric diseases or those requiring crutches preoperatively may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster recovery times and improved patient satisfaction after total knee arthroplasty.
How similar studies have performed: Previous studies have shown promising results with fast track protocols in orthopedic surgeries, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients affected by knee osteoarthritis, eligible for primary total knee arthroplasty * BMI \< 32 * Time up ang go test \</= 12 seconds * American Society of Anesthesiologists physical status classification system (ASA) \</= 2 * preoperative hemoglobin (HB) \>13 g/dl * patients eligible for spinal anesthesia * presence of a care-giver Exclusion Criteria: * psychiatric diseases * preoperative use of crutches * ASA \> 3 * preoperative HB \< 13 g/dl
Where this trial is running
Bologna
- Istituto Ortopedico Rizzli — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Cesare Stagni, MD — Istituto Ortopedico Rizzoli
- Study coordinator: Martina Rocchi, MD
- Email: martina.rocchi@ior.it
- Phone: 00393338705057
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.