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A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures

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ClinicalTrials.gov Identifier: NCT04507880
Recruitment Status : Not yet recruiting
First Posted : August 11, 2020
Last Update Posted : August 11, 2020
Sponsor:
Collaborator:
Herlev and Gentofte Hospital
Information provided by (Responsible Party):
Signe Rosner Rasmussen, Herlev and Gentofte Hospital

Study Description
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Brief Summary:
The objective of this study is to evaluated the efficacy and safety of the reverse total shoulder prosthesis (RTSA) for complex proximal humerus fractures. The clinical results of RTSA will be compared to clinical results from a historical cohort, that received a hemiarthroplasty of the shoulder.

Condition or disease Intervention/treatment Phase
Shoulder Fractures Device: Reverse Total Shoulder Arthroplasty Device: Hemiarthroplasty Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : August 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: RTSA group
Participants with a complex proximal humerus fracture given a RTSA
 Device: Reverse Total Shoulder Arthroplasty
The RTSA (GLOBAL UNITE Reverse Fracture System) from DePuy Synthes.
Active Comparator: Hemiarthroplasty group
Historical cohort of participants, operated with a hemiarthroplasty of the shoulder
 Device: Hemiarthroplasty
The shoulder hemiarthroplasty


Outcome Measures
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Primary Outcome Measures :
  1. Change in Constant score (CS) [ Time Frame: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery ]
    The CS consists of four parameters (pain, mobility, ADL, strength) assessing shoulder function after the treatment of shoulder injury, both subjectively and objectively. The scale rates from worst (0) to best (100) quality of shoulder function.


Secondary Outcome Measures :
  1. Change in Oxford Shoulder Score (OSS) [ Time Frame: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery ]
    The OSS is a patient related outcome-measure (PROM) validated for evaluating self-assessed functionality after shoulder surgery. The 12 questions, with five response options, gives a total score ranging from 12 points (no pain or functional impairment) to 60 points (worst).

  2. Change in Western Ontario Osteoarthritis of the Shoulder Index (WOOS) [ Time Frame: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery ]
    The WOOS is a patient-related outcome measurement, initially validated for patients with osteoarthritis of the shoulder. On four domains (physical symptoms, recreation/work, lifestyle, emotions) the visual analog scale measures shoulder-related quality-of-life with a maximum of 1900 points, which signifies highest quality of function.

  3. Change in EQ5D questionnaire [ Time Frame: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery ]
    The EQ-5D (EuroQuol 5 Dimension scale) questionnaire is a widely used patient-related outcome measurement for quality of life assessment in general, consisting of 25 dichotomous questions from five parameters and a visual analog scale to plot perceived health. A persons selfperceived health status is then evaluated as a 5-digit number, ranging from 11111 (having no problems) to 33333 (having problems in all 5 aspects), and as a number from 0 (worst imaginable health) to 100 (best imaginable health).

  4. Change in Numeric Ranking Scale [ Time Frame: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery ]
    Pain measured after surgery according to the Numeric Ranking Scale (NRS), where 0 is no pain and 10 is worst imaginable pain.

  5. Complications [ Time Frame: The outcome is registered 2 years after surgery ]
    Postoperative complications or reoperation due to infection, nerve damage, vascular damage, iatrogenic perioperative fracture, or loosening of the implant.

  6. Change in humeral tuberosities [ Time Frame: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery ]
    Migration or resorption of the humeral tuberosities accessed qualitatively from the xrays.


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 120 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fracture or fracture dislocation not suitable for non-operative treatment or for osteosynthesis due to displacement and comminution
  • Patients older than 65-years of age, or younger than 65-year of age if the surgeon assesses the physiological age as older.
  • All patients, regardless of age, with an insufficient or irreparable rotator cuff

Exclusion Criteria:

  • Brachial plexus palsy
  • Previous ipsilateral fracture of clavicula, scapula, or proximal humerus
  • Cognitive disabilities or substance abuse enabling rehabilitation and follow-up
  • Patients without a Danish civil registration number
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04507880


Contacts
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Contact: Signe R Rasmussen, MD +4526623427 signe.nanna.rosner.rasmussen.01@regionh.dk

Sponsors and Collaborators
Signe Rosner Rasmussen
Herlev and Gentofte Hospital
Investigators
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Study Chair: Bo S Olsen, Professor Herlev and Gentofte Hospital
More Information
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Responsible Party: Signe Rosner Rasmussen, MD, orthopedic resident, principal investigator, Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier: NCT04507880    
Other Study ID Numbers: 71005
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Signe Rosner Rasmussen, Herlev and Gentofte Hospital:
Humeral Fractures, Proximal
Additional relevant MeSH terms:
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Fractures, Bone
Humeral Fractures
Shoulder Fractures
 Wounds and Injuries
Arm Injuries
Shoulder Injuries