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Let's Agree to Disagree on Operative versus Nonoperative treatment for proximal humeral fractures. An international multicentre prospective cohort study

Nonoperative versus Operative Treatment for proximal humeral fractures. An International multicentre prospective cohort study.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26848
Enrollment
220
Registered
2021-03-24
Start date
2020-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal humeral fractures, Isolated greater tuberosity fractures

Interventions

The operative treatment will consist of open reduction and internal plate fixation (ORIF), minimal invasive plate osteosynthesis (MIPO), intramedullary nailing, or arthroplasty of the glenohumeral joi

Sponsors

DePuy Synthes
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients (>18 years) presenting acute displaced proximal humeral fracture involving minimally the surgical neck, including isolated greater tuberosity fractures will be eligible for inclusion.

Exclusion criteria

Exclusion criteria: - Open fracture - Pre-existing co-morbidities which preclude operative treatment - Pathological fractures, associated dislocation of injured shoulder joint - Associated ipsilateral upper extremity fractures - Concomitant soft tissue injury or neurovascular injuries requiring operative treatment - Delayed presentation (> 3weeks after injury) - Treatment for re-fractures - Cognitive impairment - Non-Dutch, non-German or non-English speaking patients - Patients not resident in the hospitals area and unavailable for follow-up.

Design outcomes

Primary

MeasureTime frame
Quick Dash scores at 6 weeks and 12 months

Secondary

MeasureTime frame
- The subjective shoulder value (SSV) - EuroQol five dimensional questionnaire (EQ5D) - Numerical Rating Scale (NRS) Pain score - Return to sports and work activity - Complications - Revision surgery - implant removal and related complications

Contacts

Public ContactRuben Hoepelman

UMC Utrecht

rjhoepelman@gmail.com0616079764

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)