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

NCT ID: NCT06444828

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2026-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Proximal Humeral Fracture Humeral Head Fracture

Keywords

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proximal humerus fracture Reverse Shoulder Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT, single blinded
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
non information of the type of implant used is given to the patient

Study Groups

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non operative treatment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Reverse Shoulder Arthroplasty (RSA)

RSA 135/ 155 inclination

Group Type ACTIVE_COMPARATOR

Non-operative

Intervention Type PROCEDURE

Non-operative treatment versus operative treatment (surgery)

Interventions

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Non-operative

Non-operative treatment versus operative treatment (surgery)

Intervention Type PROCEDURE

Other Intervention Names

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Surgery Reverse Shoulder Arthroplasty

Eligibility Criteria

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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),
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region of Southern Denmark

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Klaus Wilhelm Josef Hanisch

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Klaus Hanisch

Role: STUDY_CHAIR

University of Southern Denmark

Locations

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University Hospital Southern Danmark

Esbjerg, South, Denmark

Site Status

Countries

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Denmark

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://doi.org/10.1186/ISRCTN85422168

ISRCTN

Other Identifiers

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ISRCTN85422168

Identifier Type: -

Identifier Source: org_study_id