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NCT05438719
MOTUS Total Joint Replacement Investigational Device Exemption Study
NA trial testing MOTUS Total Joint Replacement in Lumbar Spine Degeneration in 158 participants. Participants enrolled and being followed up; not accepting new ones.
13 June 2026
Quick facts
| Lead sponsor | 3Spine |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 158 |
| Start date | 23 June 2022 |
| Primary completion | 13 June 2026 |
| Estimated completion | 13 June 2029 |
| Sites | 14 locations across United States |
Drugs / interventions tested
- MOTUS Total Joint Replacement
Conditions studied
- Lumbar Spine Degeneration — all drugs for Lumbar Spine Degeneration →
Sponsor
3Spine
Who can join
Adults 21 to 80, any sex, with Lumbar Spine Degeneration. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is designed to collect safety and efficacy data on patients who plan to undergo a single-level total joint replacement of the lumbar spine using the MOTUS device (MOTUS Total Joint Replacement procedure) to demonstrate noninferiority to lumbar interbody fusion with respect to composite endpoints.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Total joint replacement of the lumbar spine: report of the first two cases with 16 years of follow-up.
Nel LJ, Humphreys SC, Sielatycki JA, Block JE, et al · · 2024 · cited 5× · PMID 39399078 · DOI 10.21037/jss-24-50 -
Total Joint Replacement of the Lumbar Spine: 12-Month Pain and Functional Outcomes From an Investigational Device Exemption Clinical Trial.
Nunley PD, Sielatycki JA, Humphreys SC, Hodges SD, et al · · 2025 · cited 2× · PMID 41120216 · DOI 10.14444/8809 -
Total joint replacement of the lumbar spine: surgical technique and procedural details.
Sielatycki JA, Jorgensen AY, Khachatryan A, Geddes BJ, et al · · 2026 · PMID 42158056 · DOI 10.21037/jss-2025-aw-185
Verify or expand the search:
- PubMed search for NCT05438719
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Lumbar Spine Degeneration
Currently open trials in the same condition.
- NCT05452694 — OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults · recruiting
- NCT05746143 — The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion · Phase 4 · recruiting
- NCT04823858 — 3Spine Lumbar Fusion Real World Evidence Study · active not recruiting
- NCT05945550 — Comparison of Complication Rates Between Initial and Re-operative Anterior Lumbar Interbody Fusion Surgery: Is There a D · active not recruiting
Other 3Spine trials
Trials by the same sponsor.
- NCT04823858 — 3Spine Lumbar Fusion Real World Evidence Study · active not 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 NCT05438719 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by 3Spine
- Last refreshed: 3 December 2025
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/NCT05438719.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing