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NCT04697004
SMR Stemless Reverse Vs SMR Reverse Shoulder System
NA trial testing Investigational Arm: SMR Stemless Reverse in Arthroplasty, Replacement in 200 participants. Status unknown.
30 March 2026
Quick facts
| Lead sponsor | Limacorporate S.p.a |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 1 April 2021 |
| Primary completion | 30 March 2026 |
| Estimated completion | 30 March 2026 |
| Sites | 11 locations across United States |
Drugs / interventions tested
- Investigational Arm: SMR Stemless Reverse
- Control Arm: SMR Reverse Shoulder System
Conditions studied
- Arthroplasty, Replacement — all drugs for Arthroplasty, Replacement →
Sponsor
Limacorporate S.p.a
Who can join
22 and older, any sex, with Arthroplasty, Replacement. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function. This is a prospective, multi-center, randomized, controlled trial to demonstrate non-inferiority of the SMR Stemless Reverse to the SMR Reverse Shoulder System. Patients with joint dysfunction who continue to experience significant symptoms despite an appropriate course of non-operative management are eligible. Patients will be considered enrolled into the study when an ICF has been signed, all inclusion criteria are met and no exclusion criteria are present including intraoperative exclusion criteria, and the patient is randomized into either the SMR Stemless Reverse (investigational) group, the SMR Reverse Shoulder System (control) group or is part of the roll-in population. Enrollment is expected to take approximately 24 months.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04697004
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Limacorporate S.p.a trials
Trials by the same sponsor.
- NCT05180071 — A Post-market Study Evaluating Clinical and Radiographic Outcomes of Total Elbow Arthroplasty With TEMA · NA · not yet recruiting
- NCT05606120 — H-35 CL TRAUMA Cemented Femoral Stem · completed
- NCT05007067 — H-29 DELTA Multihole TT Study. · terminated
- NCT06870123 — Randomized MINIMA Stem with DELTA TT or DELTA ST-C · NA · active not recruiting
- NCT04884542 — Multigen Plus H Study and AMF TT Cones · 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 NCT04697004 (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 Limacorporate S.p.a
- Last refreshed: 2 October 2024
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/NCT04697004.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing