Arthrex Eclipse™ Shoulder Prosthesis

Arthrex logo

Arthrex

Status

Terminated

Conditions

Osteoarthritis

Treatments

Device: Eclipse™ Total Shoulder Replacement
Device: Univers™

Study type

Interventional

Funder types

Industry

Identifiers

NCT01790113
Arthrex 003

Details and patient eligibility

About

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.

Full 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.

Enrollment

303 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

303 participants in 2 patient groups

Univer™ II
Active Comparator group
Description:
Univers™ II Total Shoulder Replacement
Treatment:
Device: Univers™
Eclipse™
Experimental group
Description:
Eclipse™ Total Shoulder Replacement
Treatment:
Device: Eclipse™ Total Shoulder Replacement

Trial documents
1

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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