Synovectomy Clinical Trials

Clinical trials related to Synovectomy Procedure

Treatment of Acquired Idiopathic Stiffness in Revision Total Knee Arthroplasty With Hinged Knee Prosthesis With or Without Low Dose Irradiation: A Multicentre Prospective Randomized Controlled Trial

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Radiation, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Acquired idiopathic stiffness (AIS) is a common complication following total knee arthroplasty (TKA). It is caused by excessive scar formation, which leads to pain, loss of motion, and functional impairment. When early noninvasive treatments fail, some patients require more surgery. In these cases, surgeons often use a special type of replacement called a hinged prosthesis, which allows more thorough removal of scar tissue and stiffened ligaments. Unfortunately, even after more surgery, many patients continue to struggle with stiffness, pain, and impaired function. Low-dose irradiation (LDI) is a safe, established therapy for conditions with abnormal scar formation. Its role in the setting of AIS has not been defined. The goal of this study is to compare outcomes of revision TKA with or without the addition of LDI. The primary outcome is range of motion at one year following surgery. Secondary outcomes include patient-reported functional scores, repeat surgeries, and complications like wound breakdown or infection. This project has the potential to address a common, debilitating complication after TKA, improve outcomes, reduce repeat interventions and healthcare costs, and broader implementation and standardization of care.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults (≥18 years) undergoing revision TKA with a hinged prosthesis for AIS after primary TKA

• Patient with a ROM arc \<70 degrees or flexion contracture of \>20 degrees without any identifiable cause for stiffness (e.g. component oversizing, malrotation, infection, or periprosthetic fracture).

Locations
United States
California
University of Southern California
NOT_YET_RECRUITING
Los Angeles
Utah
University of Utah
NOT_YET_RECRUITING
Salt Lake City
Other Locations
Canada
Humber River Hospital
NOT_YET_RECRUITING
Toronto
Mount Sinai Hospital
RECRUITING
Toronto
Contact Information
Primary
Jesse Wolfstadt, MD, MSc
jesse.wolfstadt@sinaihealth.ca
416-586-4800
Backup
Ravianne Tuazon, BSc
Ravianne.Tuazon@sinaihealth.ca
416-586-4800
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2029-01-31
Participants
Target number of participants: 36
Treatments
Experimental: Hinged Revision TKA + Low-Dose Irradiation
Patients undergo hinged revision total knee arthroplasty (TKA) with a rotating hinge prosthesis, followed by a single session of external beam low-dose irradiation (LDI) delivering 800 cGy to the operative knee on post-operative day 1 (or post-operative day 2 if medically necessary), coordinated with radiation oncology.
Active_comparator: Hinged Revision TKA Alone
Patients undergo hinged revision total knee arthroplasty (TKA) with a rotating hinge prosthesis and receive standard postoperative care without low-dose irradiation. All perioperative care, rehabilitation, and follow-up protocols are identical to the experimental arm.
Related Therapeutic Areas
Sponsors
Leads: Mount Sinai Hospital, Canada

This content was sourced from clinicaltrials.gov