Clinical trial NCT04697004: SMR Stemless Reverse Vs SMR Reverse Shoulder System
Official title: A Randomized, Multi-Center, Prospective, Safety and Efficacy Study Comparing the Outcome of Total Reverse Shoulder Arthroplasty (RSA) with SMR Stemless Reverse Vs SMR Reverse Shoulder System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthroplasty, Replacement
Keywords: Shoulder Joint
Shoulder Replacement
Arthritis with rotator cuff tear
Post traumatic fracture sequele
Severe osteoarthritis and rotator cuff deficiency
Significant glenoid or socket side bone deformed or loss
Reoccurrence of instability or chronic shoulder dislocation
Severe osteoarthritis and stiff shoulder
Lead sponsor: Limacorporate S.p.a
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
First posted: 2021-01-06
Enrollment: 200
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The 200 randomized subjects will be randomized 1:1 to SMR Stemless Reverse and SMR Reverse Shoulder System.
Primary purpose: TREATMENT

Brief summary: The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function. This is a prospective, multi-center, randomized, controlled trial to demonstrate non-inferiority of the SMR Stemless Reverse to the SMR Reverse Shoulder System.

Patients with joint dysfunction who continue to experience significant symptoms despite an appropriate course of non-operative management are eligible. Patients will be considered enrolled into the study when an ICF has been signed, all inclusion criteria are met and no exclusion criteria are present including intraoperative exclusion criteria, and the patient is randomized into either the SMR Stemless Reverse (investigational) group, the SMR Reverse Shoulder System (control) group or is part of the roll-in population. Enrollment is expected to take approximately 24 months.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 22 years of age
2. Skeletally mature as evident by scapula and proximal humerus closure
3. Candidate for primary total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder), when clinical indications based on physical exam and medical history including one or more of the following:

   1. Arthritis with rotator cuff tear not reparable
   2. Irreparable rotator cuff tear
   3. Rotator cuff tear arthropathy
   4. Severe osteoarthritis and rotator cuff deficiency or stiff shoulder
   5. Significant glenoid or socket side bone deformed or loss
   6. Reoccurrence of instability or a chronic shoulder dislocation
   7. Any other medical reason that the investigator determine that subject is a good candidate for a reverse total shoulder arthroplasty

Exclusion Criteria:

1. BMI \> 40 kg/m2
2. Previous contralateral shoulder surgery within 3 months of enrollment or that requires active treatment (i.e. surgery or brace)
3. Had surgery in the targeted shoulder within last 12 months of enrollment, except diagnostic arthroscopy without procedures
4. Had surgery in lower limbs (such as hip or knee) within last 6 months of enrollment
5. Corticosteroid injections in the ipsilateral shoulder within 3 months of enrollment
6. Complete deltoid muscle insufficiency
7. Glenoid retroversion great than 25 degrees based off a 2D axial CT scan
8. History of/or signs and/or symptoms of local or systemic infection including but not limited to septicemia; osteomyelitis
9. Neurologically confirmed nerve lesion compromising shoulder joint function
10. Poor meta-epiphyseal bone stock compromising stability of the implant including but not limited to humeral head fracture, iatrogenic glenoid fracture, severe osteoporosis
11. Metabolic disorders which may impair fixation and stability of the implant including but not limited to uncontrolled diabetes mellitus with an HbA1C \> 7.5%
12. Extended bone loss after previous surgery defined as: complete bone loss of greater and lesser tuberosity
13. Meta-epiphyseal bony defect (including large cyst)

Primary outcomes:
measure: Primary Efficacy Endpoint-Constant Murley Score
timeFrame: 24 Months
measure: Primary Safety Endpoint-Absence of revisions, reoperations, and implant loosening.
timeFrame: 24 Months
Secondary outcomes:
measure: Secondary Efficacy Measure-Constant-Murley Score
timeFrame: 3, 6, and 12 month visits
measure: Secondary Efficacy Measure-American Shoulder and Elbow Surgeons Shoulder Score (ASES)
timeFrame: 3, 6, 12 and 24 month visits
measure: Secondary Efficacy Measure-Simple Shoulder Test (SST)
timeFrame: 3, 6, 12 and 24 month visits
measure: Secondary Efficacy Measure-EQ-5D-5L
timeFrame: 3, 6, 12 and 24 month visits
measure: Secondary Efficacy Measure-Range of Motion (ROM)
timeFrame: 3, 6, 12 and 24 month visits
measure: Secondary Efficacy Measure-Single Assessment Numeric Evaluation (SANE)
timeFrame: 3, 6, 12 and 24 month visits
measure: Secondary Safety Measure-Serious Procedure or Device Related Adverse Events
timeFrame: From enrollment to the final study visit (24 months)
measure: Secondary Safety Measure-Absence of Subsequent Secondary Surgical Interventions
timeFrame: From enrollment to the final study visit (24 months)
measure: Secondary Safety Measure-Radiographic: Standard CT and x-ray scans
timeFrame: From enrollment to the final study visit (24 months)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Kerlan-Jobe Institute
state: California
city: Denver
country: United States
facility: Western Orthopaedics
state: Colorado
city: Boca Raton
country: United States
facility: Levy Shoulder Center
state: Florida
city: Orlando
country: United States
facility: AdventHealth
state: Florida
city: Chicago
country: United States
facility: Rush Orthopaedics
state: Illinois
city: East Syracuse
country: United States
facility: Upstate Orthopedics
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Rothman Orthopaedic
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie
state: Pennsylvania
city: San Antonio
country: United States
facility: University of Texas- Health Science Center
state: Texas
Study officials:
affiliation: Rush Orthopedics
name: Grant Garrigues, M.D.
role: PRINCIPAL_INVESTIGATOR
References: