Anatomic TSA vs RTSA for Glenohumeral Arthritis
Primary Purpose
Arthritis Shoulder
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Total shoulder arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis Shoulder focused on measuring shoulder, primary osteoarthritis, Range of motion, clinical outcomes, radiographic outcomes, anatomic prosthesis, reverse prosthesis, Arthroplasty
Eligibility Criteria
Inclusion Criteria:
- Primary glenohumeral arthritis,
- Intact rotator cuff,
- No important glenoid bone loss (cf exclusion criteria),
- Patients between 65 and 85 years old
- Informed Consent as documented by signature (Appendix Informed Consent Form).
Exclusion Criteria:
- B2 glenoid with > 80% posterior humeral head subluxation or greater 25 degrees neoglenoid retroversion,
- B3 and C type glenoids,
- Full thickness rotator cuff tear,
- Acute or malunited proximal humeral fracture,
- Chronic locked dislocation
- Rheumatoid arthritis,
- Revision surgery or surgical antecedents,
- Tumors,
- Axillary nerve damage,
- Non-functioning deltoid muscle,
- Glenoid vault deficiency precluding baseplate fixation,
- Infection and neuropathic joints,
- Known or suspected non-compliance, drug or alcohol abuse,
- Patients incapable of judgement or under tutelage,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for CT scan etc. of the participant,
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
Sites / Locations
- La Tour HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Anatomic TSA
RTSA
Arm Description
The control group will receive through a deltopectoral approach an anatomic total shoulder arthroplasty (TSA) for a primary glenohumeral arthritis
The experimental group will receive through a deltopectoral approach a reverse total shoulder arthroplasty RTSA for a primary glenohumeral arthritis
Outcomes
Primary Outcome Measures
Change in American Shoulder and Elbow Surgeons score (ASES)
General clinical score (0-100, with 100 being the best score possible)
Secondary Outcome Measures
Change in Subjective Shoulder Value (SSV)
General clinical score (0-100, with 100 being the best score possible)
Change in Range of motion in degrees
(anterior forward flexion, external rotation at the side, internal rotation to nearest spinal level)
Complication rates
Change in pain on visual analogic scale (pVAS)
General clinical score (0-10, with 10 the worst score possible)
Change in Constant score
General clinical score (0-100, with 100 being the best score possible)
Change in Short Form -12 (SF-12)
General clinical score (0-100, with 100 being the best score possible)
Radiographic outcomes
Rates of aseptic loosening, implant migration, implant tilt, scapular notching, glenoid bone loss as defined previously by the investigator
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04629391
Brief Title
Anatomic TSA vs RTSA for Glenohumeral Arthritis
Official Title
Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis. A Randomized Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
June 24, 2021 (Actual)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
La Tour Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
There are no published prospective studies that compared 2-year functional outcomes of RTSA and anatomic TSA for the treatment of primary glenohumeral osteoarthritis with intact rotator cuffs and no excessive glenoid retroversion. The primary goal of our prospective randomized study is to determine whether RTSA have at least as good results as anatomic TSA (non-inferiority), in patients with glenohumeral osteoarthritis, without rotator cuff tears nor significant glenoid retroversion.
Detailed Description
Total anatomic shoulder arthroplasty (TSA) is an effective treatment of severe glenohumeral osteoarthritis, with significant improvement in shoulder pain and function. Concerns about glenoid loosening, associated with difficult revision procedures and disappointing outcomes, have however been raised.
Reverse total shoulder arthroplasty (RTSA) was designed with a medialized center of rotation to treat cuff tear arthropathy. Favorable early reports led to the expansion of primary indications of RTSA to proximal humeral fractures as well as osteoarthritis with poor glenoid bone stock. Recent reports revealed excellent clinical results of RTSA for primary glenohumeral arthropathy with intact rotator cuff and a low rate of complications.
Retrospective studies comparing functional results - of anatomic TSA for treating glenohumeral osteoarthritis with RTSA for rotator cuff arthropathy - found equivalent or greater improvements in American Shoulder and Elbow Surgeons score (ASES) at >2-year follow-up. In a study comparing anatomic TSA to RTSA for the treatment of glenohumeral osteoarthritis with intact rotator cuffs, Steen et al. reported equivalent functional results at >2-year follow-up. The retrospective matched cohort study could, however, not eliminate biases, such that RTSA patients had higher preoperative glenoid retroversion than anatomic TSA patients. The authors therefore hypothesize that, in patients treated for glenohumeral osteoarthritis without excessive glenoid retroversion, RTSA will render better functional outcomes than anatomic TSA, at 2 postoperative years. Many other studies confirmed in 2019 Steen's hypothesis. Moreover, several studies revealed good long-term survivorship after RTSA.
There are no published prospective studies that compared 2-year functional outcomes of RTSA and anatomic TSA for the treatment of primary glenohumeral osteoarthritis with intact rotator cuffs and no excessive glenoid retroversion. The primary goal of our prospective randomized study is to determine whether RTSA have at least as good results as anatomic TSA (non-inferiority), in patients with glenohumeral osteoarthritis, without rotator cuff tears nor significant glenoid retroversion.The secondary goals are 1) to evaluate whether RTSA eventually grants superior postoperative clinical and radiographic outcomes than anatomic TSA (superiority), 2) to determine whether RTSA is associated with fewer postoperative complications than anatomic TSA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis Shoulder
Keywords
shoulder, primary osteoarthritis, Range of motion, clinical outcomes, radiographic outcomes, anatomic prosthesis, reverse prosthesis, Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
While the patients and care providers will be aware of the type of prosthesis, the physicians who assessed the outcomes and analyzed the data will be blinded to this information.
Allocation
Randomized
Enrollment
296 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anatomic TSA
Arm Type
Active Comparator
Arm Description
The control group will receive through a deltopectoral approach an anatomic total shoulder arthroplasty (TSA) for a primary glenohumeral arthritis
Arm Title
RTSA
Arm Type
Experimental
Arm Description
The experimental group will receive through a deltopectoral approach a reverse total shoulder arthroplasty RTSA for a primary glenohumeral arthritis
Intervention Type
Device
Intervention Name(s)
Total shoulder arthroplasty
Intervention Description
A prosthesis (either anatomic or reverse) will be implanted in shoulders patients that suffer from primary glenohumeral arthritis.
Primary Outcome Measure Information:
Title
Change in American Shoulder and Elbow Surgeons score (ASES)
Description
General clinical score (0-100, with 100 being the best score possible)
Time Frame
Between baseline and 2 postoperative years
Secondary Outcome Measure Information:
Title
Change in Subjective Shoulder Value (SSV)
Description
General clinical score (0-100, with 100 being the best score possible)
Time Frame
Between baseline and 2 postoperative years
Title
Change in Range of motion in degrees
Description
(anterior forward flexion, external rotation at the side, internal rotation to nearest spinal level)
Time Frame
Between baseline and 2 postoperative years
Title
Complication rates
Time Frame
2 postoperative years.
Title
Change in pain on visual analogic scale (pVAS)
Description
General clinical score (0-10, with 10 the worst score possible)
Time Frame
Between baseline and 2 postoperative years
Title
Change in Constant score
Description
General clinical score (0-100, with 100 being the best score possible)
Time Frame
Between baseline and 2 postoperative years
Title
Change in Short Form -12 (SF-12)
Description
General clinical score (0-100, with 100 being the best score possible)
Time Frame
Between baseline and 2 postoperative years
Title
Radiographic outcomes
Description
Rates of aseptic loosening, implant migration, implant tilt, scapular notching, glenoid bone loss as defined previously by the investigator
Time Frame
2 postoperative years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary glenohumeral arthritis,
Intact rotator cuff,
No important glenoid bone loss (cf exclusion criteria),
Patients between 65 and 85 years old
Informed Consent as documented by signature (Appendix Informed Consent Form).
Exclusion Criteria:
B2 glenoid with > 80% posterior humeral head subluxation or greater 25 degrees neoglenoid retroversion,
B3 and C type glenoids,
Full thickness rotator cuff tear,
Acute or malunited proximal humeral fracture,
Chronic locked dislocation
Rheumatoid arthritis,
Revision surgery or surgical antecedents,
Tumors,
Axillary nerve damage,
Non-functioning deltoid muscle,
Glenoid vault deficiency precluding baseplate fixation,
Infection and neuropathic joints,
Known or suspected non-compliance, drug or alcohol abuse,
Patients incapable of judgement or under tutelage,
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for CT scan etc. of the participant,
Enrolment of the investigator, his/her family members, employees and other dependent persons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Lädermann, MD
Phone
+41 22 719 75 55
Email
alexandre.laedermann@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Lädermann, MD
Organizational Affiliation
La Tour Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
La Tour Hospital
City
Meyrin
ZIP/Postal Code
1217
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Lädermann, MD
Phone
+41 22 719 75 55
Email
alexandre.laedermann@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Anatomic TSA vs RTSA for Glenohumeral Arthritis
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