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NCT03383991
Reverse Total Shoulder Arthroplasty Versus Hemiarthroplasty for Displaced 3- and 4-part Proximal Humeral Fractures
NA trial testing Reverse Total Shoulder Arthroplasty in Humeral Fracture, Proximal. Completed in 2 September 2020.
2 September 2020
Quick facts
| Lead sponsor | Karolinska Institutet |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Primary purpose | treatment |
| Start date | 10 September 2013 |
| Primary completion | 2 September 2020 |
| Estimated completion | 2 September 2020 |
Drugs / interventions tested
- Reverse Total Shoulder Arthroplasty
- Hemiarthroplasty
Conditions studied
- Humeral Fracture, Proximal — all drugs for Humeral Fracture, Proximal →
Sponsor
Karolinska Institutet
Who can join
70 and older, any sex, with Humeral Fracture, Proximal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Proximal humeral fractures are common injuries with the highest incidence being amongst the elderly. Most proximal humeral fractures are nondisplaced or minimally displaced. The majority of these are reliably treated nonoperatively with an acceptable functional outcome. The treatment of displaced fractures is more controversial. Consensus is lacking as to when surgery is indicated or what type of procedure to choose if surgery is elected. Displaced 3- and 4-part fractures where internal fixation is deemed unreliable have been considered an indication for hemiarthroplasty. Hemiarthroplasty gives reasonable control of pain but the resulting shoulder function and range of motion is unpredictable. The use of reverse total shoulder arthroplasty is increasing and might result in a better range of motion then hemiarthroplasty. The aim of this multicenter study is to test the hypothesis that reverse total shoulder arthroplasty gives better shoulder function than hemiarthroplasty for displaced 3- and 4-part proximal humeral fractures.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03383991
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Reverse Total Shoulder Arthroplasty
Trials testing the same drug.
- NCT04507880 — A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures · NA · unknown
Other recruiting trials for Humeral Fracture, Proximal
Currently open trials in the same condition.
- NCT04113044 — Go Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS® · active not recruiting
Other Karolinska Institutet trials
Trials by the same sponsor.
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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 NCT03383991 (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 Karolinska Institutet
- Last refreshed: 2 September 2020
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/NCT03383991.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing