Arthrex Eclipse™ Shoulder Prosthesis

• Sponsor: Arthrex, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01790113
• Collaborator: (none)
• Enrollment: 303
• Locations: 16
• Arms: 2
• Actual Duration (Months): 76
• Patients Per Site: 18.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

A Prospective, Randomized, Multicenter Study comparing the Safety and Effectiveness of Arthrex's Eclipse™ Shoulder to the Univers™ II Shoulder Prosthesis in patients with a degenerative joint disease.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Device: Univers™; Device: Eclipse™ Total Shoulder Replacement	N/A

Detailed Description

The purpose of this study is to demonstrate non-inferiority of the Arthrex Eclipse™ Shoulder Prosthesis to the Arthrex Univers™ II Shoulder Prosthesis for the treatment of degenerative joint disease in subjects who are candidates for total shoulder replacement. Non-inferiority in terms of safety and effectiveness will be measured by a 2 year composite clinical success (CCS) that requires functional improvement, radiographic success, absence of reoperations and revision, and lack of serious device-related adverse events.

Study Design

• Study Type: Interventional
• Actual Enrollment: 303 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomized, Multicenter Study Comparing the Safety and Effectiveness of Arthrex's Eclipse™ Shoulder Prothesis to the Univers™ II Shoulder Prosthesis in Patients With a Degenerative Joint Disease
• Actual Study Start Date: Feb 4, 2013
• Actual Primary Completion Date: Jun 7, 2019
• Actual Study Completion Date: Jun 7, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Univer™ II Univers™ II Total Shoulder Replacement	Device: Univers™; Control
Experimental: Eclipse™ Eclipse™ Total Shoulder Replacement	Device: Eclipse™ Total Shoulder Replacement; Investigational

Outcome Measures

Primary Outcome Measures

1. Composite Clinical Success [2 year]

   To be considered a success, the eclipse subject must meet the following composite clinical success criteria: An improvement in the Adjusted Constant Score (for pain, Function, and range of motion) from baseline (pre-op) to the 24 month time-point that is > or = to 10 and a final Adjusted Constant Score > or + to 54. Radiographic success at the Month 24 time-point which is defined as absence of clinically significant humeral radiolucency, humeral migration/subsidence (relative to 3 month time-point), glenoid migration/subsidence (relative to the 3 month time-point), device disassembly or fracture, and/or periprosthetic fracture, as described in the radiographic protocol. No reoperation, removal or modification of any study component up to the subject's completion of the study. No serious device-related complications up to the subject's completion of the study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The subject is > 21 years of age

• The subject has continued symptoms in target shoulder despite at least 3 months of other treatment modalities(e.g.: anti-inflammatory, physical therapy and steroid injections)

• The subject has a diagnosis in the target shoulder of one or more of the following:

osteoarthritis, avascular necrosis, post-traumatic arthritis, or rheumatoid arthritis.

• The subject presents with pain and functional impairment in the index shoulder, measured by an Adjusted Constant Score of ≤50. Note: The Adjusted Constant Score will be calculated from the raw Constant Score to establish patient eligibility.

• The subject is willing to receive implantation of the Arthrex™ Shoulder Prosthesis or Univers™ II Shoulder Prosthesis.

• The subject must be physically and mentally willing and able to comply with all study procedures (including follow-up visits and radiographic assessments) until the conclusion of the study.

• The subject has been informed of the nature of the study and provided written consent as approved by the sites local Institutional Review Board or Ethic Review Board.

Exclusion Criteria:

• The subject is likely a candidate for hemi-humeral arthroplasty (i.e.: Avascular Necrosis of the humeral head without glenoid involvement (Stages 0-3): Rotator Cuff Deficient Shoulder: Glenoid Bone deficiency/deformity that precludes glenoid replacement (Walch Type B2 or C) or Fractures of the Proximal Humerus, without Glenoid involvement.

• The subject has immature bone as defined by the absence of cancellous bone patterning, a mature, thick cortex, and stress lines within the cancellous bone.

• The subject has obvious defects in bone quality, such as cysts or lesions, in the humeral head of the target shoulder, as demonstrated by radiographic evaluation.

• The subject has a target shoulder a rotator cuff that is not intact and not reconstructible.

• The subject has Irreducible 3- and 4- part proximal humeral fractures of the target shoulder.

• The subject has documented history of foreign-body sensitivity.

• Subject with positive pregnancy test, or lactating, or intends to become pregnant during treatment period

• The subject has history of Schizophrenia, Bipolar Disorder and/or Major Depressive Disorder as defined by DSM IV.

• The subject is skeletally immature demonstrated radiographically by incomplete closure of proximal humeral epiphyses.

• The subject is at high risk for poor healing or confounding outcomes [(i.e.: clinically significant renal, hepatic, cardiac hematologic disease or endocrine disease)]

• The subject is on immune-stimulating or immunosuppressive agents

• The subject has co-morbidity that reduces life expectancy < 36 month.

• The subject seeking or receiving workman's compensation for shoulder injury,

• The subject is > 350 lbs.

• The subject engaged in heavy labor (e.g. repetitive lifting in the excess of more than 50 lbs.)

• The subject has had surgery in the affected shoulder in the last 12 months (with the exception of diagnostic arthroscopy without reconstruction or repair procedures)

• The subject is engaged in active sports participation. (e.g. weight lifting involving upper extremities or involved in contact sports)

• The subject is taking medications known to potentially interfere with bone/soft tissue healing (e.g. steroids with the exception of topical and/or inhalers)

• The subject is a prisoners or wards of the state

• The subject has a history of alcohol and/or substance abuse as defined by DSM IV (Diagnostic and Statistical Manual Diploma in Social Medicine)

• The subject has an active or chronic infection, either systemic or local.

• The subject has pathologic fractures of the affected shoulder

• The subject has acute trauma of the affected shoulder

• The subject has osteoporosis defined as a bone density T score of < or = -2.5. (A screening Questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation) and MORES (Male Osteoporosis Risk Estimation Score), will be used to screen patients who require a DEXA (dual energy x-ray absorptiometry) bone mineral density measurement.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banner Research	Sun City	Arizona	United States	85351
2	Orthopedics Stanford University	Redwood City	California	United States	94063
3	Western Orthopaedics	Denver	Colorado	United States	80218
4	Midwest Orthopaedics at Rush	Chicago	Illinois	United States	60612
5	Ellis and Badenhausen Orthopedics PSC	Louisville	Kentucky	United States	40223
6	Medstar Health Research Institute	Hyattsville	Maryland	United States	20782
7	Peninsula Orthopaedics Associates, P.A.	Salisbury	Maryland	United States	21804
8	Essentia Health Duluth	Duluth	Minnesota	United States	55805
9	Excelsior Orthopedics	Amherst	New York	United States	14226
10	SUNY Upstate Medical Universtiy	East Syracuse	New York	United States	13057
11	Adena Health System	Chillicothe	Ohio	United States	45601
12	OhioHealth Research Institute at Grant Medical Center	Columbus	Ohio	United States	43215
13	Southern Oregon Orthopedics	Medford	Oregon	United States	97504
14	University Orthopedics	Altoona	Pennsylvania	United States	16602
15	Rothman Institute	Philadelphia	Pennsylvania	United States	19108
16	Palmetto Health Orthopedics (formerly Providence Orthopedics Group, LLC_Moore Orthopedics)	Columbia	South Carolina	United States	29203

Sponsors and Collaborators

• Arthrex, Inc.

Investigators

• Study Director: Melissa Hirschberg, Arthrex, Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 15, 2019

More Information

Publications

None provided.

• Responsible Party: Arthrex, Inc.
• ClinicalTrials.gov Identifier: NCT01790113
• Other Study ID Numbers: Arthrex 003
• First Posted: Feb 13, 2013
• Last Update Posted: Feb 3, 2021
• Last Verified: Oct 1, 2019

• Additional relevant MeSH terms: Osteoarthritis

Study Results

Participant Flow

Recruitment Details	In February 2013, the first subject was enrolled in the study and the last subject was enrolled in August 2018. Subjects were enrolled at both academic and private study sites.
Pre-assignment Detail	The treated population was 303 subject, with 224 Eclipse subjects and 79 Univers II subjects.

Arm/Group Title	Univers™ II	Eclipse™
Arm/Group Description	Univers™ II Total Shoulder Replacement Univers™: Control	Eclipse™ Total Shoulder Replacement Eclipse™ Total Shoulder Replacement: Investigational
Period Title: Overall Study
STARTED	79	224
COMPLETED	76	149
NOT COMPLETED	3	75

Baseline Characteristics

Arm/Group Title	Active Comparator: Univer II	Experimental: Eclipse	Total
Arm/Group Description	Univer II Total Shoulder Replacement	Eclipse Total shoulder Replacement	Total of all reporting groups
Overall Participants	79	224	303
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	66	66	66
Sex: Female, Male (Count of Participants)
Female	22 27.8%	66 29.5%	88 29%
Male	57 72.2%	158 70.5%	215 71%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	0 0%	4 1.8%	4 1.3%
Unknown or Not Reported	79 100%	220 98.2%	299 98.7%
Region of Enrollment (Count of Participants)
United States	79 100%	224 100%	303 100%

Outcome Measures

1. Primary Outcome

Title	Composite Clinical Success
Description	To be considered a success, the eclipse subject must meet the following composite clinical success criteria: An improvement in the Adjusted Constant Score (for pain, Function, and range of motion) from baseline (pre-op) to the 24 month time-point that is > or = to 10 and a final Adjusted Constant Score > or + to 54. Radiographic success at the Month 24 time-point which is defined as absence of clinically significant humeral radiolucency, humeral migration/subsidence (relative to 3 month time-point), glenoid migration/subsidence (relative to the 3 month time-point), device disassembly or fracture, and/or periprosthetic fracture, as described in the radiographic protocol. No reoperation, removal or modification of any study component up to the subject's completion of the study. No serious device-related complications up to the subject's completion of the study.
Time Frame	2 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Univer™ II	Eclipse™
Arm/Group Description	Univers™ II Total Shoulder Replacement Univers™: Control	Eclipse™ Total Shoulder Replacement Eclipse™ Total Shoulder Replacement: Investigational
Measure Participants	61	132
Number [percentage of success rate]	89.7	92.3

Adverse Events

Time Frame	24 months
Arm/Group Title	Active Comparator: Univer II		Experimental: Eclipse
Arm/Group Description	Univer II Total Shoulder Replacement		Eclipse Total shoulder Replacement
All Cause Mortality
	Active Comparator: Univer II		Experimental: Eclipse
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/79 (0%)		1/224 (0.4%)
Serious Adverse Events
	Active Comparator: Univer II		Experimental: Eclipse
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/79 (15.2%)		26/224 (11.6%)
Blood and lymphatic system disorders
Anemia	1/79 (1.3%)	1	0/224 (0%)	0
Abnormal Blood levels	0/79 (0%)	0	1/224 (0.4%)	1
Blood Cancer	0/79 (0%)	0	2/224 (0.9%)	2
Venous thrombosis	1/79 (1.3%)	2	0/224 (0%)	0
Cardiac disorders
Atrial fibrillation	1/79 (1.3%)	1	1/224 (0.4%)	1
Cardia Arrest	1/79 (1.3%)	1	0/224 (0%)	0
Chest Pain	0/79 (0%)	0	2/224 (0.9%)	2
Bradycardia	1/79 (1.3%)	1	0/224 (0%)	0
Endocrine disorders
Cushing	0/79 (0%)	0	1/224 (0.4%)	1
Gastrointestinal disorders
abdominal Pain	1/79 (1.3%)	1	1/224 (0.4%)	1
Colonic perforation	0/79 (0%)	0	1/224 (0.4%)	1
gastric obstruction	0/79 (0%)	0	1/224 (0.4%)	1
General disorders
Non device /procedure related SAE	10/79 (12.7%)	12	18/224 (8%)	21
Cancer	3/79 (3.8%)	3	1/224 (0.4%)	1
Infections and infestations
UTI	1/79 (1.3%)	1	2/224 (0.9%)	2
Musculoskeletal and connective tissue disorders
Device -Related SAE	0/79 (0%)	0	2/224 (0.9%)	2
Procedure Related	2/79 (2.5%)	2	6/224 (2.7%)	7
Arthritis	3/79 (3.8%)	3	8/224 (3.6%)	8
Nervous system disorders
Paresthesia	0/79 (0%)	0	2/224 (0.9%)	2
Renal and urinary disorders
Urinary retention	3/79 (3.8%)	3	0/224 (0%)	0
Respiratory, thoracic and mediastinal disorders
Hypoxia	1/79 (1.3%)	1	0/224 (0%)	0
Vascular disorders
CVA	1/79 (1.3%)	1	0/224 (0%)	0
Other (Not Including Serious) Adverse Events
	Active Comparator: Univer II		Experimental: Eclipse
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	42/79 (53.2%)		54/224 (24.1%)
Blood and lymphatic system disorders
Anemia	9/79 (11.4%)	11	13/224 (5.8%)	16
Cardiac disorders
Cardiac disorders	14/79 (17.7%)	16	11/224 (4.9%)	11
Musculoskeletal and connective tissue disorders
Arthritis	14/79 (17.7%)	17	27/224 (12.1%)	34
Joint swelling	5/79 (6.3%)	5	3/224 (1.3%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.