Back to resultsA 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures
Primary Purpose
Shoulder Fractures
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reverse Total Shoulder Arthroplasty
Hemiarthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Fractures focused on measuring Humeral Fractures, Proximal
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RTSA group
Hemiarthroplasty group
Arm Description
Participants with a complex proximal humerus fracture given a RTSA
Historical cohort of participants, operated with a hemiarthroplasty of the shoulder
Outcomes
Primary Outcome Measures
Change in Constant score (CS)
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
Change in Oxford Shoulder Score (OSS)
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).
Change in Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
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.
Change in EQ5D questionnaire
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).
Change in Numeric Ranking Scale
Pain measured after surgery according to the Numeric Ranking Scale (NRS), where 0 is no pain and 10 is worst imaginable pain.
Complications
Postoperative complications or reoperation due to infection, nerve damage, vascular damage, iatrogenic perioperative fracture, or loosening of the implant.
Change in humeral tuberosities
Migration or resorption of the humeral tuberosities accessed qualitatively from the xrays.
Full Information
NCT ID
NCT04507880
First Posted
July 31, 2020
Last Updated
August 8, 2020
Sponsor
Signe Rosner Rasmussen
Collaborators
Herlev and Gentofte Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04507880
Brief Title
A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures
Official Title
A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2020 (Anticipated)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Signe Rosner Rasmussen
Collaborators
Herlev and Gentofte Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Fractures
Keywords
Humeral Fractures, Proximal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RTSA group
Arm Type
Experimental
Arm Description
Participants with a complex proximal humerus fracture given a RTSA
Arm Title
Hemiarthroplasty group
Arm Type
Active Comparator
Arm Description
Historical cohort of participants, operated with a hemiarthroplasty of the shoulder
Intervention Type
Device
Intervention Name(s)
Reverse Total Shoulder Arthroplasty
Intervention Description
The RTSA (GLOBAL UNITE Reverse Fracture System) from DePuy Synthes.
Intervention Type
Device
Intervention Name(s)
Hemiarthroplasty
Intervention Description
The shoulder hemiarthroplasty
Primary Outcome Measure Information:
Title
Change in Constant score (CS)
Description
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.
Time Frame
The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
Secondary Outcome Measure Information:
Title
Change in Oxford Shoulder Score (OSS)
Description
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).
Time Frame
The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
Title
Change in Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
Description
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.
Time Frame
The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
Title
Change in EQ5D questionnaire
Description
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).
Time Frame
The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
Title
Change in Numeric Ranking Scale
Description
Pain measured after surgery according to the Numeric Ranking Scale (NRS), where 0 is no pain and 10 is worst imaginable pain.
Time Frame
The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
Title
Complications
Description
Postoperative complications or reoperation due to infection, nerve damage, vascular damage, iatrogenic perioperative fracture, or loosening of the implant.
Time Frame
The outcome is registered 2 years after surgery
Title
Change in humeral tuberosities
Description
Migration or resorption of the humeral tuberosities accessed qualitatively from the xrays.
Time Frame
The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Signe R Rasmussen, MD
Phone
+4526623427
Email
signe.nanna.rosner.rasmussen.01@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo S Olsen, Professor
Organizational Affiliation
Herlev and Gentofte Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures
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