Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04924205 · ClinicalTrials.gov registry record · NA
A Comparison Of Primary TKA Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy
A NA study of Arthropathy of Knee, sponsored by Nicolas Noiseux, MD, MS, FRCSC.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT04924205: Recruiting NA study of Arthropathy of Knee, sponsored by Nicolas Noiseux, MD, MS, FRCSC.
NCT04924205 is a NA study of Arthropathy of Knee that is actively recruiting participants, run by Nicolas Noiseux, MD, MS, FRCSC. The registered enrollment target is 80 participants, roughly in line with the 80-participant average among 6 other Arthropathy of Knee trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04924205, a NA study of Arthropathy of Knee, is actively recruiting participants, sponsored by Nicolas Noiseux, MD, MS, FRCSC.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
This will be a prospective, randomized, noninferiority clinical trial comparing rehabilitation methods post-total knee arthroplasty (TKA). Population of interest is adult hip/knee clinic patients over age 18 who are indicated for unilateral primary total knee arthroplasty. All TKA patients are prescribed physical therapy (PT) for rehabilitation post-operatively. The investigators will compare this current treatment with a new, validated, wearable smart knee brace (FM2 Knee Brace) that can be used for rehabilitation post-TKA. Following enrollment in the study, the investigators will match and randomize participants into two cohorts (outpatient PT versus FM2 Knee Brace). Outpatient PT group will be prescribed routine six-week course of outpatient PT (no pool exercises, remainder at therapist's discretion) to start as soon as possible upon discharge. The FM2 Knee Brace group will complete device set up at pre-op visit and will be prescribed 3-4 exercises to complete at their discretion over six weeks. The investigators will collect measurements of knee flexion, extension, total arc of motion at pre-op visit and at 6-week, 3-month, and 1-year post-op visits. The investigators will also plan to record additional PROs, therapy compliance, and complication rates. The investigators will compare the two groups to test whether the new FM2 Knee Brace is noninferior to regular PT when recovering from TKA, and if the new technology could be an alternative to outpatient PT.
Primary Outcome
The study will collect measurements of knee flexion, extension, total arc of motion, and will also plan to record therapy compliance and complication rates. The two groups will be compared to study if the FM2 Knee Brace group is clinically non-inferior to the standard PT group with respect to knee range of motion.
Conditions Studied
Interventions
- DEVICE FM2 Knee Brace
Study Locations (1)
Iowa
- University of Iowa Hospitals & Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2025-04 |
| Phase | NA |
What NCT04924205 shows while recruiting
NCT04924205 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, roughly in line with the 80-participant average among 6 other Arthropathy of Knee trials with a reported enrollment target.
The record links to 1 condition, with Arthropathy of Knee appearing as the primary indexed condition, and to 1 intervention - of which FM2 Knee Brace is the first listed.
NCT04924205 reports a single indexed study location in Iowa.
Frequently Asked Questions
What is clinical trial NCT04924205 about?
NCT04924205 is a clinical study titled "A Comparison Of Primary TKA Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy". This will be a prospective, randomized, noninferiority clinical trial comparing rehabilitation methods post-total knee arthroplasty (TKA). Population of interest is adult hip/knee clinic patients over age 18 who are indicated for unilateral primary total knee arthroplasty. All TKA patients are presc...
What is the current status of trial NCT04924205?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2021-09-01. Estimated completion is 2025-04.
What conditions does trial NCT04924205 study?
This clinical trial studies the following conditions: Arthropathy of Knee.
What interventions are being tested in trial NCT04924205?
The interventions under investigation include: FM2 Knee Brace (DEVICE).
Who is sponsoring clinical trial NCT04924205?
This trial is sponsored by Nicolas Noiseux, MD, MS, FRCSC, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04924205 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Arthropathy of Knee
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Nirvana Super Pro Supplementation in Orthopedic Surgery Patients
RECRUITING · NA
-
Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery
RECRUITING · NA
-
Triathlon All-Polyethylene Tibia Outcomes Study
ACTIVE NOT RECRUITING · NA
-
The Effect of Light Therapy on Post-Surgical Pain
ACTIVE NOT RECRUITING · NA
-
Opioid Education in Total Knee Arthroplasty
COMPLETED · NA
-
Evaluation of the Duration of Bupivacaine Spinal Block in Orthopedic Procedures With and Without Epinephrine Wash
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01243931 · 80 participants · NA
Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy
- NCT01659203 · 80 participants · Phase 1
Proton or Photon RT for Retroperitoneal Sarcomas
- NCT01803451 · 80 participants · Early Phase 1
Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass
- NCT01964859 · 80 participants · Phase 2
Feasibility Study for Fibroblast Autologous Skin Grafts
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI