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Rehabilitation Following Displaced Proximal Humerus Fractures

Primary Purpose

Shoulder Fractures

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Pain management and shoulder bandage
One-time physiotherapy instruction
Usual rehabilitation care
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Fractures focused on measuring Proximal humerus fractures, Proximal humeral fractures, Randomized controlled trial, Shoulder fractures, Non-operative treatment, Rehabilitation

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Patients aged 60 years or above with displaced PHFs (Neer's definition) including 2-, 3-, or 4-part fractures after a low energy trauma will be recruited.

Prior to first visit in the outpatient clinic all patients with PHFs will be screened for eligibility based on initial radiographs and medical records by an experienced orthopaedic consultant (senior author SB) at Zealand University Hospital, Køge, Denmark. The senior author classifies fracture categories.

• Patients should be cognitively capable of answering patient-reported outcome measures.

Exclusion Criteria:

  • Dependent on daily personal care for basic activities of daily living
  • Diagnosed with dementia or institutionalized
  • Does not understand written and spoken guidance in Danish
  • Pathological fracture or previous fracture in the same proximal humerus
  • Concomitant injury or fracture.
  • Polytrauma, high-energy trauma, or multiple fractures
  • Fracture dislocation or articular surface fracture
  • Isolated tuberosity fracture
  • Fractures not expected to heal by non-surgical treatment (no bony contact between head and shaft in both views)
  • The senior author considers the patient unsuitable to attend the study for medical reasons (substance abuse, affective or psychotic disorders, apoplexy, chronic pain, malignant disease)
  • Symptomatic glenohumeral osteoarthritis, rheumatoid arthritis, or rotator cuff-arthropathy

Sites / Locations

  • Department of Orthopaedics, Zealand University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

One-time physiotherapy instruction

Usual rehabilitation care

Arm Description

One-time physiotherapy instruction and no usual rehabilitation care

One-time physiotherapy instruction and usual rehabilitation care

Outcomes

Primary Outcome Measures

Oxford Shoulder Score (OSS)
Patient administered shoulder specific score, score ranges between between 0 and 48, with a higher score implying a greater degree of disability.

Secondary Outcome Measures

European Quality of life-5 Dimensions-Three-Level (EQ-5D-3L)
Health-related quality of life, index score: < 0 to 1 (full health), with anchoring of death as 0.
European Quality of life-5 Dimensions-Three-Level (EQ-5D-3L)
Health-related quality of life, index score: < 0 to 1 (full health), with anchoring of death as 0.
Conversion to surgery
Number of patients converting to surgery
Oxford Shoulder Score (OSS)
Patient administered shoulder specific score, score ranges between between 0 and 48, with a higher score implying a greater degree of disability.

Full Information

First Posted
March 14, 2022
Last Updated
July 24, 2023
Sponsor
Zealand University Hospital
Collaborators
University of Southern Denmark, University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT05302089
Brief Title
Rehabilitation Following Displaced Proximal Humerus Fractures
Official Title
The Effect of Rehabilitation Following Non-surgical Management of Displaced Proximal Humerus Fractures: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital
Collaborators
University of Southern Denmark, University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Proximal humerus fractures (PHFs) are the third most common non-vertebral fractures in the elderly. Most elderly experience loss of function following a PHF regardless of treatment. A Cochrane review from 2015 concluded that surgical management is not superior to non-surgical management, and that the optimal non-surgical management after PHF is not known. Therefore, the aim of this study is to evaluate the effectiveness of usual rehabilitation care after displaced PHF compared with one-time physiotherapy instruction.
Detailed Description
Proximal humerus fractures (PHFs) are the closely related to osteoporosis. The lifetime risk of suffering a PHF in females aged 50 or above is 13%. About half of the fractures are minimally displaced and usually managed by short immobilization, analgetics, and early mobilization. The remaining half of the patients suffer from displaced fractures, traditionally managed surgically by open reduction and internal fixation or shoulder replacement. Within the last decades, an increasing number of high-quality randomized controlled trials (RCTs) and meta-analyses have failed to document the superiority of surgical management in displaced PHFs. Therefore, an increasing number of patients are being offered nonsurgical treatment consisting of immobilization followed by rehabilitation that may vary across countries and regions. Most elderly experience loss of function following a PHF regardless of treatment. However, optimal management and recovery of function are paramount to prevent a substantial impact on the patient's independent living and morbidity. A systematic review and metaanalysis from 2021 concluded a need for high-quality RCTs to substantiate the current evidence regarding the need for supervision after a PHF. It is assumed that rehabilitation delivered as structured training benefits patients with PHFs, but this is not known from current evidence. It is possible that patients are even harmed with intensive training programmes. Most RCTs with a non-surgically treated group use the same exercise intervention in the two groups to best identify the difference between surgery and non-surgical treatment. Therefore, the effect of training cannot be concluded from these studies. This is supported by an expectation of more nonsurgically treated displaced PHFs due to the growing evidence of no benefit from surgery. The current study is a prerequisite for future rehabilitation studies comparing different training modalities. Therefore, this study aims is to evaluate the effectiveness of usual rehabilitation care after displaced PHF compared with one-time physiotherapy instruction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Fractures
Keywords
Proximal humerus fractures, Proximal humeral fractures, Randomized controlled trial, Shoulder fractures, Non-operative treatment, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Patients will not know the direction of our hypothesis. A blinded statistician will perform the primary analysis.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
One-time physiotherapy instruction
Arm Type
Experimental
Arm Description
One-time physiotherapy instruction and no usual rehabilitation care
Arm Title
Usual rehabilitation care
Arm Type
Active Comparator
Arm Description
One-time physiotherapy instruction and usual rehabilitation care
Intervention Type
Other
Intervention Name(s)
Pain management and shoulder bandage
Intervention Description
All Patients receive standard pain management according to the local guidelines and a sling and swathe on the day of injury. After 10 to 14 days, all patients will receive a sling for optional use for one to two weeks and be randomized after oral and written informed consent.
Intervention Type
Other
Intervention Name(s)
One-time physiotherapy instruction
Intervention Description
Patients are offered a one-time physiotherapy instruction about the course of pain and suggestions for quick and safe return to activities of daily living within the first three months post-injury.
Intervention Type
Other
Intervention Name(s)
Usual rehabilitation care
Intervention Description
At the visit 10-14 days after the injury, the orthopaedic consultant (senior author SB) will refer the patient to usual rehabilitation care with a physiotherapist in a municipality close to the patient´s home. The physiotherapist then schedules the start date, typically three weeks after the injury. The rehabilitation content and duration is planned according to the choice of the local treating physiotherapist in consultation with the patient.
Primary Outcome Measure Information:
Title
Oxford Shoulder Score (OSS)
Description
Patient administered shoulder specific score, score ranges between between 0 and 48, with a higher score implying a greater degree of disability.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
European Quality of life-5 Dimensions-Three-Level (EQ-5D-3L)
Description
Health-related quality of life, index score: < 0 to 1 (full health), with anchoring of death as 0.
Time Frame
6 months
Title
European Quality of life-5 Dimensions-Three-Level (EQ-5D-3L)
Description
Health-related quality of life, index score: < 0 to 1 (full health), with anchoring of death as 0.
Time Frame
12 months
Title
Conversion to surgery
Description
Number of patients converting to surgery
Time Frame
6 months
Title
Oxford Shoulder Score (OSS)
Description
Patient administered shoulder specific score, score ranges between between 0 and 48, with a higher score implying a greater degree of disability.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
European Quality of life-5 Dimensions-Three-Level (EQ-5D-3L) visual analogue scale
Description
The patient's own health 'today' is rated between 0 (worst imaginable health) and 100 (best imaginable health)
Time Frame
6 months
Title
European Quality of life-5 Dimensions-Three-Level (EQ-5D-3L) visual analogue scale
Description
The patient's own health 'today' is rated between 0 (worst imaginable health) and 100 (best imaginable health)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Patients aged 60 years or above with displaced PHFs (Neer's definition) including 2-, 3-, or 4-part fractures after a low energy trauma will be recruited. Prior to first visit in the outpatient clinic all patients with PHFs will be screened for eligibility based on initial radiographs and medical records by an experienced orthopaedic consultant (senior author SB) at Zealand University Hospital, Køge, Denmark. The senior author classifies fracture categories. • Patients should be cognitively capable of answering patient-reported outcome measures. Exclusion Criteria: Dependent on daily personal care for basic activities of daily living Diagnosed with dementia or institutionalized Does not understand written and spoken guidance in Danish Pathological fracture or previous fracture in the same proximal humerus Concomitant injury or fracture. Polytrauma, high-energy trauma, or multiple fractures Fracture dislocation or articular surface fracture Isolated tuberosity fracture Fractures not expected to heal by non-surgical treatment (no bony contact between head and shaft in both views) The senior author considers the patient unsuitable to attend the study for medical reasons (substance abuse, affective or psychotic disorders, apoplexy, chronic pain, malignant disease) Symptomatic glenohumeral osteoarthritis, rheumatoid arthritis, or rotator cuff-arthropathy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Behnam Liaghat, MSc
Phone
+4526826801
Email
blia@regionsjaelland.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Stig Brorson, PhD
Phone
+4530574682
Email
sbror@regionsjaelland.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Behnam Liaghat, MSc
Organizational Affiliation
Zealand University Hospital, University of Southern Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stig Brorson, PhD
Organizational Affiliation
Zealand University Hospital, University of Copenhagen
Official's Role
Study Director
Facility Information:
Facility Name
Department of Orthopaedics, Zealand University Hospital
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Behnam U Liaghat, MSc
Phone
+4526826801
Email
bliaghat@health.sdu.dk
First Name & Middle Initial & Last Name & Degree
Stig Brorson, PhD
Phone
+4530574682
Email
sbror@regionsjaelland.dk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Anonymised data on group level will be made available upon reasonable request after the primary publications have been published.
Citations:
PubMed Identifier
36253041
Citation
Liaghat B, Brorson S. Effect of structured rehabilitation versus non-structured rehabilitation following non-surgical management of displaced proximal humerus fractures: a protocol for a randomised clinical trial. BMJ Open. 2022 Oct 17;12(10):e064156. doi: 10.1136/bmjopen-2022-064156.
Results Reference
derived

Learn more about this trial

Rehabilitation Following Displaced Proximal Humerus Fractures

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