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NCT01790113

Arthrex Eclipse™ Shoulder Prosthesis

Terminated NA Results posted Last updated 3 February 2021
What this trial tests

NA trial testing Univers™ in Osteoarthritis in 303 participants. Terminated before completion.

Timeline
4 February 2013
Primary endpoint
7 June 2019
7 June 2019

Quick facts

Lead sponsorArthrex, Inc.
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment303
Start date4 February 2013
Primary completion7 June 2019
Estimated completion7 June 2019
Sites16 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Arthrex, Inc. — full company profile →

Who can join

21 and older, any sex, with Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Composite Clinical Success Primary · 2 year

To be considered a success, the eclipse subject must meet the following composite clinical success criteria: 1. 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. 2. 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

GroupValue95% CI
Univer™ II89.7
Eclipse™92.3

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active Comparator: Univer II
Serious: 12/79 (15%)
Deaths: 0/79
Experimental: Eclipse
Serious: 26/224 (12%)
Deaths: 1/224

Serious adverse events (22 terms)

ReactionSystemActive Comparator: Univer IIExperimental: Eclipse
Non device /procedure related SAEGeneral disorders
ArthritisMusculoskeletal and connective tissue disorders
Procedure RelatedMusculoskeletal and connective tissue disorders
CancerGeneral disorders
Urinary retentionRenal and urinary disorders
Device -Related SAEMusculoskeletal and connective tissue disorders
Blood CancerBlood and lymphatic system disorders
Chest PainCardiac disorders
UTIInfections and infestations
ParesthesiaNervous system disorders
Atrial fibrillationCardiac disorders
AnemiaBlood and lymphatic system disorders
Abnormal Blood levelsBlood and lymphatic system disorders
Cardia ArrestCardiac disorders
BradycardiaCardiac disorders
CushingEndocrine disorders
abdominal PainGastrointestinal disorders
Colonic perforationGastrointestinal disorders
gastric obstructionGastrointestinal disorders
HypoxiaRespiratory, thoracic and mediastinal disorders
Venous thrombosisBlood and lymphatic system disorders
CVAVascular disorders
Other adverse events (4 terms — click to expand)

ReactionSystemActive Comparator: Univer IIExperimental: Eclipse
ArthritisMusculoskeletal and connective tissue disorders
Cardiac disordersCardiac disorders
AnemiaBlood and lymphatic system disorders
Joint swellingMusculoskeletal and connective tissue disorders

Most-reported serious reactions: Non device /procedure related SAE, Arthritis, Procedure Related, Cancer, Urinary retention, Device -Related SAE, Blood Cancer, Chest Pain.

Data from ClinicalTrials.gov NCT01790113 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Total shoulder arthroplasty: are the humeral components getting shorter?
    Harmer L, Throckmorton T, Sperling JW. · · 2016 · cited 51× · PMID 26801933 · DOI 10.1007/s12178-016-9313-3
  2. Shoulder replacement surgery for osteoarthritis and rotator cuff tear arthropathy.
    Craig RS, Goodier H, Singh JA, Hopewell S, et al · · 2020 · cited 34× · PMID 32315453 · DOI 10.1002/14651858.cd012879.pub2

Verify or expand the search:

Other recruiting trials for Osteoarthritis

Currently open trials in the same condition.

Other Arthrex, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01790113.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing