Back to resultsClinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder
Primary Purpose
Osteoarthritis of the Shoulder
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Total joint arthroplasty of the glenohumeral joint
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Shoulder focused on measuring osteoarthritis, shoulder, joint replacement
Eligibility Criteria
Inclusion Criteria:
- Trial participants need primary total shoulder replacement due to primary osteoarthritis or post-traumatic osteoarthritis
- Trial participants are willing to take part in the clinical trial and intend to be available for the planned follow-up examinations.
- Male, female and various subjects with age on the day of surgery from 18 to 80 years inclusive.
- Subjects agree not to participate in any other clinical trial for at least 2 years (+ 3 weeks) using the index procedure. This includes clinical trials of medication, invasive procedures and medical devices. Questionnaire-based studies or other studies that are non-invasive and do not involve drug use are allowed.
- Exclusion of intraoperative circumstances that require the implantation of a prosthesis type other than that provided for in the clinical trial (depending on the surgeon).
Exclusion Criteria:
- Previous operation on the rotator cuff of the affected shoulder
- Dysfunctional rotator cuff
- Infection of the affected shoulder joint or systemic infection
- Pregnant or breastfeeding women and those who are planning to become pregnant for up to 2 years (+3 weeks) using the index procedure
Sites / Locations
- Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE AnnastiftRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Shoulder prosthesis system GLOBAL ICON from DePuy
SIMPLICITY shoulder prosthesis system from Wright Medical
Arm Description
The GLOBAL ICON stemless is a shaftless shoulder prosthesis system for anatomical reconstruction of the shoulder joint in cases of total or hemiarthroplasty in the shoulder. The base plate consists of titanium coated with hydroxyapatite, the head of cobalt-chrome.
The SIMPLICITY is a shaftless shoulder prosthesis system for anatomical reconstruction of the shoulder joint in cases of total or hemiarthroplasty in the shoulder. The base plate consists of titanium coated with hydroxyapatite, the head of cobalt-chrome.
Outcomes
Primary Outcome Measures
Constant-Murley Score (CMS)
The CMS covers different aspects of shoulder pathology: pain, activities of daily living, range of motion and strength. The possible maximum total score is 100 points (best function). Pain and activities of daily living are answered by the patient; range of motion and strength are answered by the orthopaedic surgeon.
Constant-Murley Score (CMS)
The CMS covers different aspects of shoulder pathology: pain, activities of daily living, range of motion and strength. The possible maximum total score is 100 points (best function). Pain and activities of daily living are answered by the patient; range of motion and strength are answered by the orthopaedic surgeon.
Constant-Murley Score (CMS)
The CMS covers different aspects of shoulder pathology: pain, activities of daily living, range of motion and strength. The possible maximum total score is 100 points (best function). Pain and activities of daily living are answered by the patient; range of motion and strength are answered by the orthopaedic surgeon.
Secondary Outcome Measures
Oxford Shoulder Score (OSS)
The Oxford Shoulder Score (OSS) is a 12-item patient-reported questionnaire specifically designed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Scores from each question are added so the overall score ranges from 12 to 60 with 12 being the best out-come.
Oxford Shoulder Score (OSS)
The Oxford Shoulder Score (OSS) is a 12-item patient-reported questionnaire specifically designed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Scores from each question are added so the overall score ranges from 12 to 60 with 12 being the best out-come.
Oxford Shoulder Score (OSS)
The Oxford Shoulder Score (OSS) is a 12-item patient-reported questionnaire specifically designed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Scores from each question are added so the overall score ranges from 12 to 60 with 12 being the best out-come.
Short Form Health 36 (SF-36)
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health consisting of eight scaled scores. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Short Form Health 36 (SF-36)
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health consisting of eight scaled scores. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Short Form Health 36 (SF-36)
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health consisting of eight scaled scores. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04468178
Brief Title
Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder
Official Title
Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
January 17, 2024 (Anticipated)
Study Completion Date
March 17, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hannover Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary goal of the clinical trial is to determine that the GLOBAL ICON implant system from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with an already established prosthetic system (SIMPLICITY, Wright Medical).
Detailed Description
The primary goal of the clinical trial is to determine that the GLOBAL ICON implant system from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with an already established prosthetic system (SIMPLICITY, Wright Medical).
As secondary endpoints, the migration behavior of the humeral components over time will be determined by radiostereometric analysis (RSA), the further clinical-functional results and the satisfaction of the patients treated will be investigated. Clinical outcomes are measured using standardized and reproducible clinical scores (Oxford Shoulder Score -OSS and Short Form Health 36-SF-36 v1.0 ) at each time of examination.
Other endpoints include revision rate within the follow-up period, surgical time (incision to suture), and delays in surgical procedures due to instrumentation.
The times of data acquisition are the admission day before the operation to determine the preoperative status, the discharge day and the follow-up appointments after 3 months, 6 months, 12 months and 24 months to determine the postoperative status and course.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Shoulder
Keywords
osteoarthritis, shoulder, joint replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, randomized controlled mono-centric study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Shoulder prosthesis system GLOBAL ICON from DePuy
Arm Type
Experimental
Arm Description
The GLOBAL ICON stemless is a shaftless shoulder prosthesis system for anatomical reconstruction of the shoulder joint in cases of total or hemiarthroplasty in the shoulder. The base plate consists of titanium coated with hydroxyapatite, the head of cobalt-chrome.
Arm Title
SIMPLICITY shoulder prosthesis system from Wright Medical
Arm Type
Active Comparator
Arm Description
The SIMPLICITY is a shaftless shoulder prosthesis system for anatomical reconstruction of the shoulder joint in cases of total or hemiarthroplasty in the shoulder. The base plate consists of titanium coated with hydroxyapatite, the head of cobalt-chrome.
Intervention Type
Device
Intervention Name(s)
Total joint arthroplasty of the glenohumeral joint
Intervention Description
The arthroplasty of the glenohumeral joint will be performed as an anatomical reconstruction after primary or post-traumatic osteoarthritis.
Primary Outcome Measure Information:
Title
Constant-Murley Score (CMS)
Description
The CMS covers different aspects of shoulder pathology: pain, activities of daily living, range of motion and strength. The possible maximum total score is 100 points (best function). Pain and activities of daily living are answered by the patient; range of motion and strength are answered by the orthopaedic surgeon.
Time Frame
3 months postoperative
Title
Constant-Murley Score (CMS)
Description
The CMS covers different aspects of shoulder pathology: pain, activities of daily living, range of motion and strength. The possible maximum total score is 100 points (best function). Pain and activities of daily living are answered by the patient; range of motion and strength are answered by the orthopaedic surgeon.
Time Frame
12 months postoperative
Title
Constant-Murley Score (CMS)
Description
The CMS covers different aspects of shoulder pathology: pain, activities of daily living, range of motion and strength. The possible maximum total score is 100 points (best function). Pain and activities of daily living are answered by the patient; range of motion and strength are answered by the orthopaedic surgeon.
Time Frame
24 months postoperative
Secondary Outcome Measure Information:
Title
Oxford Shoulder Score (OSS)
Description
The Oxford Shoulder Score (OSS) is a 12-item patient-reported questionnaire specifically designed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Scores from each question are added so the overall score ranges from 12 to 60 with 12 being the best out-come.
Time Frame
3 months postoperative
Title
Oxford Shoulder Score (OSS)
Description
The Oxford Shoulder Score (OSS) is a 12-item patient-reported questionnaire specifically designed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Scores from each question are added so the overall score ranges from 12 to 60 with 12 being the best out-come.
Time Frame
12 months postoperative
Title
Oxford Shoulder Score (OSS)
Description
The Oxford Shoulder Score (OSS) is a 12-item patient-reported questionnaire specifically designed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Scores from each question are added so the overall score ranges from 12 to 60 with 12 being the best out-come.
Time Frame
24 months postoperative
Title
Short Form Health 36 (SF-36)
Description
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health consisting of eight scaled scores. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
3 months postoperative
Title
Short Form Health 36 (SF-36)
Description
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health consisting of eight scaled scores. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
12 months postoperative
Title
Short Form Health 36 (SF-36)
Description
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health consisting of eight scaled scores. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
24 months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Trial participants need primary total shoulder replacement due to primary osteoarthritis or post-traumatic osteoarthritis
Trial participants are willing to take part in the clinical trial and intend to be available for the planned follow-up examinations.
Male, female and various subjects with age on the day of surgery from 18 to 80 years inclusive.
Subjects agree not to participate in any other clinical trial for at least 2 years (+ 3 weeks) using the index procedure. This includes clinical trials of medication, invasive procedures and medical devices. Questionnaire-based studies or other studies that are non-invasive and do not involve drug use are allowed.
Exclusion of intraoperative circumstances that require the implantation of a prosthesis type other than that provided for in the clinical trial (depending on the surgeon).
Exclusion Criteria:
Previous operation on the rotator cuff of the affected shoulder
Dysfunctional rotator cuff
Infection of the affected shoulder joint or systemic infection
Pregnant or breastfeeding women and those who are planning to become pregnant for up to 2 years (+3 weeks) using the index procedure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tomas Smith, PD Dr.
Phone
+49 511 5354 310
Email
tomas.smith@diakovere.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomas Smith, PD Dr.
Organizational Affiliation
Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
City
Hanover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomas Smith, PD Dr.
Phone
+49 511 5354
Ext
310
Email
tomas.smith@diakovere.de
First Name & Middle Initial & Last Name & Degree
Tomas Smith, PD Dr.
12. IPD Sharing Statement
Learn more about this trial
Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder
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