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NCT04060251
Is There an Alternative to Immediate Home Physical Therapy Following Total Knee Arthroplasty
NA trial testing CyMedica e-vive™ System; CY-1000 in Total Knee Arthroplasty in 21 participants. Terminated before completion.
17 January 2022
Quick facts
| Lead sponsor | Wolfgang Fitz, M.D. |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 21 |
| Start date | 4 April 2019 |
| Primary completion | 17 January 2022 |
| Estimated completion | 17 January 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- CyMedica e-vive™ System; CY-1000
- iGetBetter telemedicine physical therapy
Conditions studied
- Total Knee Arthroplasty — all drugs for Total Knee Arthroplasty →
Sponsor
Wolfgang Fitz, M.D.
Who can join
18 and older, any sex, with Total Knee Arthroplasty. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: 148 days (21.14 weeks). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Other adverse events (1 terms — click to expand)
| Reaction | System | Group 1, iGetBetter Group | Group 2, E-vive Group | Group 3, Physical Therapy … |
|---|---|---|---|---|
| Advanced Home PT Required | General disorders | — | — | — |
Data from ClinicalTrials.gov NCT04060251 adverse events section.
Sponsor's own description
The purpose of this study is to evaluate how different pre-operative therapeutic approaches affect quad strength and patient satisfaction after total knee replacements. There are three treatments groups: standard physical therapy protocol, the use of CyMedica NMES garments, and a telemedical home therapy program.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04060251
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Total Knee Arthroplasty
Currently open trials in the same condition.
- NCT07524387 — Femoral Triangle Block vs Adductor Canal Block on Early Quadriceps Function After Total Knee Arthroplasty · NA · recruiting
- NCT07511842 — REST-Knee: A Pilot RCT of 72-Hour Knee Immobilization and Pain Outcomes · NA · recruiting
- NCT07324954 — Methylene Blue in Total Knee Arthroplasty (TKA) · Phase 1 · recruiting
- NCT07336160 — ERAS-Based Preoperative Nutrition and Fasting in Total Knee Arthroplasty · NA · recruiting
- NCT07371390 — Minimal Sedation During Knee Replacement Surgery · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04060251 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Wolfgang Fitz, M.D.
- Last refreshed: 7 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04060251.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing