Last reviewed · How we verify
NCT04827277
TSA Versus RSA in Patients >75
NA trial testing Reverse Total Shoulder Replacement in Total Shoulder Arthoplasty in 108 participants. Status unknown.
15 April 2022
Quick facts
| Lead sponsor | Rothman Institute Orthopaedics |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 108 |
| Start date | 15 April 2021 |
| Primary completion | 15 April 2022 |
| Estimated completion | 15 April 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Reverse Total Shoulder Replacement
- Anatomic Total Shoulder Replacement
Conditions studied
- Total Shoulder Arthoplasty — all drugs for Total Shoulder Arthoplasty →
Sponsor
Rothman Institute Orthopaedics
Who can join
75 and older, any sex, with Total Shoulder Arthoplasty. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Total shoulder arthroplasty (TSA) has proven to be a predictable and successful operation for the treatment of symptomatic glenohumeral osteoarthritis (GHOA) with an intact rotator cuff. Results after TSA have not been as good in cases with rotator cuff dysfunction, however. Early glenoid loosening, shoulder pain and the need for revision surgery has been all associated with rotator cuff deficiency. Even in cases without tears, fatty infiltration of the rotator cuff has been associated with inferior outcomes in TSA. Advanced age has been shown to be associated with increased fatty infiltration of the rotator cuff in shoulders with primary osteoarthritis. Because of this, one may propose that surgeons should avoid the potential complications with TSA and perform RSA for patients with advanced age. It is thus the purpose of this study to evaluate the patient reported outcomes (PROs) of total shoulder arthroplasty (TSA) compared with reverse shoulder arthroplasty (RSA) in patients \>75 years of age
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04827277
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Rothman Institute Orthopaedics trials
Trials by the same sponsor.
- NCT06903767 — Automated V Manual Impactor Study · NA · enrolling by invitation
- NCT06601803 — Surgiphor Us in TSA · Phase 4 · enrolling by invitation
- NCT06575010 — Exparel v Dexamethasone in RCR · Phase 4 · enrolling by invitation
- NCT06536842 — Wound Drain After Lumbar Fusion Surgery · NA · enrolling by invitation
- NCT06484192 — Pain Control After Lumbar Spine Fusion · Phase 4 · enrolling by invitation
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 NCT04827277 (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 Rothman Institute Orthopaedics
- Last refreshed: 1 April 2021
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/NCT04827277.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing