Comparing Outcomes of Non-surgical Versus Surgical Treatment of Shoulder Fractures With Different Shoulder Replacements

NCT06444828 | Active Not Recruiting

• 1 other identifier: ISRCTN85422168
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The optimal treatment of complex shoulder fracture is controversial. In general, non-surgical treatment is recommended for older patients, but results are often unsatisfying. Therefore different surgical approaches have been tried to improve outcomes for this group of patients. Reverse shoulder arthroplasty has shown promising results for these types of fractures and changes in the design of the implant might improve outcomes further. The aim of this study is to compare the outcomes of complex shoulder fractures after non-surgical versus surgical treatment and compare two different types of implants.

Conditions

Proximal Humeral Fracture; Humeral Head Fracture

Keywords

proximal humerus fracture; Reverse Shoulder Arthroplasty

Outcome Measures

Primary Outcomes (1)

• The primary outcome is Western Ontario Osteoarthritis of the Shoulder Index (WOOS)

  All participants are assessed with online questionnaire, Patient Related Outcome Measurement (PROM) 0-100% (100% best), validated

  one years follow up (FU)

Secondary Outcomes (3)

• Constant Murley score

  one and two years FU

• Subjective shoulder Volume (SSV)

  one and two years FU

• x-rays

  one and two years FU

Study Arms (2)

non operative treatment

NO INTERVENTION

Proximal humeral fractures (PHF) treated non-operative, Rehabilitation only

Reverse Shoulder Arthroplasty (RSA)

ACTIVE COMPARATOR

RSA 135/ 155 inclination

Procedure: Non-operative

Interventions

Non-operative PROCEDURE

Non-operative treatment versus operative treatment (surgery)

Also known as: Surgery Reverse Shoulder Arthroplasty

Reverse Shoulder Arthroplasty (RSA)

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Displaced Proximal Humeral Fractures (PHF) Neer type III or IV / AO B\&C. Radiological confirmed

You may not qualify if:

• other types of PHF, Head splits, gleno-humeral dislocations, pathological fractures. Refuse to participate in the study. Non-compliant, drug/alcohol abuse or institutionalized, (Low-cooperative),

Sponsors & Collaborators

• University of Southern Denmark: lead
• Region of Southern Denmark: collaborator

Study Sites (1)

University Hospital Southern Danmark

Esbjerg, South, 6700, Denmark

Location

Related Links

• ISRCTN

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Study Officials

• Klaus Hanisch

  University of Southern Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: non information of the type of implant used is given to the patient
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: RCT, single blinded

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: June 6, 2024
• Study Start: September 1, 2021
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)