Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years

NCT06416618 | Recruiting DMC

• 1 other identifier: PHF5065
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief Summary

The goal of this clinical trial is to study whether surgery results in better functional outcomes than non-surgical treatment among patients aged 50-65 with a displaced proximal humerus fracture. The main questions it aims to answer are:

• Does osteosynthesis result in better patient-reported functional outcomes compared to non-surgical treatment at 12 months follow-up? Aim is also to characterize the patient group aged 50-65 regarding fracture morphology, osteoporosis, and clinical frailty scale. The study compare operation with either plate or nail fixation to non-surgical treatment. Participants will:
• Receive either surgical treatment or non-surgical treatment.
• At 6 months, 1 year, and 2 years, the patient will answer two short questionnaires (Oxford Shoulder Score and Eq-5D-3L). The primary outcome will be Oxford Shoulder Score at 12 months. The secondary outcome will be OSS at 6 and 24 months and EQ-5D-3L score measured at the same time-points. Adverse events and conversion to surgery will be registered. OSS and EQ-5D-3L will be completed just before the 6 months visit.

Conditions

Proximal Humeral Fracture; Shoulder Fractures

Outcome Measures

Primary Outcomes (1)

• Oxford Shoulder Score 12 months

  Oxford Shoulder Score is a patient-reported shoulder-specific outcome measure. It is a patient-administrated questionnaire to assess shoulder function. It consists of 12 questions on a 5-point Likert scale (both pain- and function-related), each offering five ordinal response options. The cumulative score ranges between 0 and 48, being 0 (worst) to 48 (best: no pain or no functional limitation).

  12 months

Secondary Outcomes (4)

• Oxford Shoulder Score

  6 and 24 months

• EQ-5D-3L

  6, 12 and 24 months

• Conversion to surgery after inclusion, or additional surgery

  24 months

• Adverse events.

  24 months

Study Arms (2)

Non-surgical treatment

EXPERIMENTAL

Patients in the non-surgical group will be offered an optional sling for comfort for an additional 1-2 weeks at their first visit,

Procedure: Non surgical

Procedure: Surgical treatment

ACTIVE COMPARATOR

The surgical group will receive osteosynthesis with a locking plate or an intramedullary locking nail, according to the surgeon's choice

Procedure: Surgical

Interventions

Surgical PROCEDURE

Surgical group: After osteosynthesis, they will be provided with a sling and swathe immediately after the surgery. From the first postoperative day, only the sling will be used. Two weeks postoperatively, patients will undergo clinical and radiological follow-up in the outpatient clinic. They will be referred to post-operative rehabilitation in the municipalities. At 12 weeks postoperatively, patients will have another clinical and radiological follow-up. This is the current standard care for surgical treatment with a plate or intramedullary nail.

Procedure: Surgical treatment

Non surgical PROCEDURE

Non-surgical group: Patients in the non-surgical group will be offered an optional sling for comfort for an additional 1-2 weeks at their first visit, 10-14 days post-injury. Patients will be referred to rehabilitation in the municipalities. At week 6 post-injury, all patients will undergo clinical and radiological follow-up. This represents the current standard care for non-surgical treatment of displaced PHF at the departments.

Non-surgical treatment

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 50 and 65 years with a displaced PHF assessed to be constructible by the treating surgeon after a low-energy trauma will be considered for eligibility.
• Patients should be cognitively capable of answering the follow-up questionnaires.

You may not qualify if:

• The patient does not understand written and spoken native language (Danish or Finnish/Swedish)
• Inability to give informed consent
• Fractures assessed to be unreconstructedly by the treating surgeon
• Isolated tuberosity fracture, fracture dislocations, open fractures, and fractures with involvement of the articular surface
• Less than 25% contact between head fragment and metaphysis/diaphysis measured at two perpendicular radiographs at two weeks.
• Pathological fractures or previous fractures in the same proximal humerus
• Concomitant fractures, which could influence the outcome
• Paralysis in upper extremity

Sponsors & Collaborators

• Zealand University Hospital: lead
• Tampere University Hospital: collaborator

Study Sites (2)

Centre for Evidence-Based Orthopaedics, Zealand University Hospital

Køge, Region Sjælland, 4600, Denmark

RECRUITING

Tampere University Hospital

Tampere, 33520, Finland

NOT YET RECRUITING

Related Publications (5)

• Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

  PMID: 35727196 BACKGROUND

• Alispahic N, Brorson S, Bahrs C, Joeris A, Steinitz A, Audige L. Complications after surgical management of proximal humeral fractures: a systematic review of event terms and definitions. BMC Musculoskelet Disord. 2020 May 26;21(1):327. doi: 10.1186/s12891-020-03353-8.

  PMID: 32456631 BACKGROUND

• Brorson S, Alispahic N, Bahrs C, Joeris A, Steinitz A, Audige L. Complications after non-surgical management of proximal humeral fractures: a systematic review of terms and definitions. BMC Musculoskelet Disord. 2019 Feb 23;20(1):91. doi: 10.1186/s12891-019-2459-6.

  PMID: 30797232 BACKGROUND

• Audige L, Brorson S, Durchholz H, Lambert S, Moro F, Joeris A. Core set of unfavorable events of proximal humerus fracture treatment defined by an international Delphi consensus process. BMC Musculoskelet Disord. 2021 Nov 30;22(1):1002. doi: 10.1186/s12891-021-04887-1.

  PMID: 34847888 BACKGROUND

• Houkjaer L, Launonen AP, Sumrein BO, Karna L, Issa Z, Holtz KB, Brorson S. Surgical versus non-surgical treatment of proximal humerus fracture in patients aged 50-65 years: young shoulder CARE (displaCed proximAl humeRus fracturE) trial-a pragmatic randomized controlled trial study protocol. Trials. 2025 Dec 29;26(1):588. doi: 10.1186/s13063-025-09283-x.

  PMID: 41466383 DERIVED

Related Links

• EMEA: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

MeSH Terms

Conditions

Shoulder Fractures

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Study Officials

• Line Løjbert Houkjær, M.D.

  Center for evidensbaseret ortopædkirurgi, Sjællands Universitets Hospital, Køge.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Line Løjbert Houkjær, M.D., ph.d.-student

CONTACT

61711681; lihol@regionsjaelland.dk

Stig Brorson, Prof.

CONTACT

sbror@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary investigator will conduct the blinded statistical analysis through data anonymization and will be supervised by a biostatistician. After the blinded statistical analysis has been completed, two abstracts will be written based on the pre-blinding analysis results before the blinding is revealed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, M.D.

Model Details: The study is a two-center, parallel-group, randomized, superiority trial

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 16, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); FI (1)