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

Outcome Following Reverse Shoulder Arthroplasty for Acute Proximal Humerus Fractures in Patients 60 Years of Age and Older With Different Inclination Implants Versus Non-surgical Treatment- Trial Protocol: a Prospective RCT, Single Blinded

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Proximal Humeral Fracture; Humeral Head Fracture
• Intervention / Treatment: Procedure: Non-operative

Detailed Description

The optimal treatment of proximal humeral fracture (PHF) Neer type III and IV AO B1.1,1.2 and C1.1,3.1 is controversial. National guidelines for Denmark have been published in 2015 and updated 2019. They recommend conservative treatment to all kinds of PHF for patients aged above 60 years. Exceptions are fracture-dislocations, headsplits or surgical conditions, where intervention is mandatory like open fractures and impaired nerve- and circulation.

Recently reverse shoulder arthroplasty (RSA) has gained expanding popularity in treating PHF . Compared with osteosynthesis (ORIF) or hemiarthroplasty (HA) outcomes were superior , . The importance of tuberosity healing for good functional outcomes has lead to development of different implants and fixation techniques. The original RSA design by Grammont with 155 degree inclination of the humeral stem was made for cuff-arthropathy. This design moves the center of rotation in a medial direction, and increase the tension on the tuberosities.

In contrast "anatomical" designed humeral implants with 135 degree enables more anatomical refixation of the tuberosities with less tension and might reduce the risk of resorption or displacement of the fragments. To implant a 155 degree RSA the surgeon has to remove parts of the rotator cuff, to enable the sliding rotation. On the other hand with a 135 degree inclination humeral component, a cuff sparing technique is possible.

The aim of this study is to compare outcomes of two different designed RSA stems versus conservative treatment of PHF Neer type III or IV / AO B&C.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • South
    • Esbjerg, South, Denmark, 6700
      • University Hospital Southern Danmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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),

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: non operative treatment; Proximal humeral fractures (PHF) treated non-operative, Rehabilitation only
Active Comparator: Reverse Shoulder Arthroplasty (RSA); RSA 135/ 155 inclination	Procedure: Non-operative; Non-operative treatment versus operative treatment (surgery); Other Names: Surgery Reverse Shoulder Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant Murley score	All participants are assessed with function scores. 0-100% (100% best) by physiotherapist	one and two years FU
Subjective shoulder Volume (SSV)	All participants are assessed with online questionnaire PROM 0-100% (100% best)	one and two years FU
x-rays	stating healing, displacement, resorbtion of the tuberosities	one and two years FU

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Region of Southern Denmark
• Investigators: Study Chair: Klaus Hanisch, University of Southern Denmark

Publications and helpful links

Helpful Links

• ISRCTN

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Reverse Shoulder Arthroplasty; proximal humerus fracture
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: ISRCTN85422168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No