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NCT03912116
Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty
NA trial testing CLARIX FLO in Osteoarthritis: Joint Replacement Surgery. Withdrawn.
16 December 2019
Quick facts
| Lead sponsor | BioTissue Holdings, Inc |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Start date | 9 April 2019 |
| Primary completion | 16 December 2019 |
| Estimated completion | 16 December 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- CLARIX FLO — full drug profile →
- Saline
Conditions studied
- Osteoarthritis: Joint Replacement Surgery — all drugs for Osteoarthritis: Joint Replacement Surgery →
Sponsor
BioTissue Holdings, Inc — full company profile →
Who can join
18 and older, any sex, with Osteoarthritis: Joint Replacement Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Total knee arthroplasty (TKA) is the most common joint replacement surgery and its incidence is expected to increase 673% to 3.48 million procedures annually by 2030. After more than 20 years of follow-up data, TKA is confirmed to be an effective treatment for knee osteoarthritis, however, postoperative pain management continues to be a challenge despite advances in surgical techniques and anesthetic practice to minimize discomfort and enhance recovery. This acute post-surgical pain caused by extensive tissue damage and inflammation in TKA leads to restricted post-operative knee range of motion (ROM) and ability to mobilize.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03912116
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other BioTissue Holdings, Inc trials
Trials by the same sponsor.
- NCT06780306 — A Study in the Treatment of Mild to Moderate Dry Eye Disease Comparing Saline to TTAX03. · Phase 2 · completed
- NCT06236308 — TTAX03 for the Treatment of Lumbosacral Facet Joint Pain · Phase 1 · withdrawn
- NCT05079035 — Lyophilized and Micronized Particulate Human Amniotic and Umbilical Cord (TTAX03) for KL Grade 3-4 Knee OA · Phase 2 · completed
- NCT04450693 — Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II) · Phase 3 · completed
- NCT04176120 — Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU) · Phase 3 · completed
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 NCT03912116 (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 BioTissue Holdings, Inc
- Last refreshed: 18 December 2019
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/NCT03912116.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing