Knee Replacement Clinical Trials

Clinical trials related to Knee Replacement Procedure

Multimodal Prehabilitation of Frail Patients 70 Years and Older Undergoing Elective Knee or Hip Replacement: A Pilot Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Background: Frailty is a geriatric syndrome of reduced physiologic reserve that increases surgical risk and is common among older adults undergoing hip or knee replacement. While prehabilitation has shown promise in enhancing outcomes, evidence from randomized controlled trials (RCTs) in frail orthopedic patients is limited.

Objective: This study aims to evaluate the feasibility and preliminary data on the effectiveness of a multimodal prehabilitation program for frail patients undergoing elective hip or knee arthroplasty.

Methods: A pilot RCT will be conducted at Landspítali-University Hospital. Patients ≥70 years scheduled for surgery with ≥2 months waiting time will be screened for frailty using PRISMA-7, the Clock Drawing Test, and Timed Up \& Go. Patients screening positive for any of the three screening tools will be randomized to multimodal prehabilitation or standard of care. The intervention includes comprehensive geriatric assessment, medication review, tailored physiotherapy using the Otago Exercise Programme, and nutritional counseling if at risk of malnutrition. We will conduct an external pilot for feasibility measures (overall enrollment, recruitment, retention, adherence). Secondary outcomes include physical performance, postoperative complications, patient-reported health status (WOMAC scale) and quality of life (EQ-5D-5L ), length of primary hospital stay, discharge location, falls postoperatively, 180-day readmission and 180-day mortality. Significance: This trial may aid in the design of larger RCT study and provide a signal of the role of multimodal prehabilitation on outcomes, including quality of life and health status among frail arthroplasty patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 70
Healthy Volunteers: f
View:

• Patients aged 70 years or older assigned to undergo hip/knee replacement at Landspítali University Hospital.

• Inclusion will be offered to patients who have previously presented at the outpatient orthopedic department and been scheduled for an elective (with a waiting period ≥2 months before surgery) hip/knee replacement.

• Patients who are willing to participate and sign informed consent and are willing to be randomized to the control or intervention arm.

Locations
Other Locations
Iceland
Landspitali University hospital
RECRUITING
Reykjavik
Contact Information
Primary
Martin I Sigurdsson, MD, PhD
mingi@hi.is
+354-824-8282
Backup
Luis G Rabelo, MD
lgr2@hi.is
+3548203587
Time Frame
Start Date: 2026-03-20
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 50
Treatments
Experimental: Prehabilitation group
This arm will undergo the intervention (multimodal prehabilitation).
No_intervention: Control group
This arm will be the control group and will not undergo the intervention (prehabilitation). The standard of care for patients undergoing elective prosthesis surgery who present at the perioperative services prior to surgery includes a preoperative appointment with a physiotherapist to guide postoperative recovery and the use of assistive devices, a consultation with a nurse to review preoperative hygiene measures such as showering, and a telephone consultation with an anesthetist for preoperative evaluation, risk assessment, and review of routine laboratory tests (e.g., blood work). As part of this process, medications, including blood thinners and anticoagulants, are adjusted as needed. In addition, patients receive education regarding perioperative management and anesthesia, with further work-up performed on an as-needed basis. Usually, patients present within 1-4 weeks before surgery.
Sponsors
Collaborators: Landspitali University Hospital
Leads: University of Iceland

This content was sourced from clinicaltrials.gov