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Cemented Humeral Stem, Uncemented Humeral Stem

Phase 3

Osteoarthritis | Unknown | Musculoskeletal |Zimmer Biomet Holdings, Inc.|Last Updated: Jan 29, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment160
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00158418Cemented vs. Non-Cemented TSA for OA of the ShoulderPHASE3 COMPLETED 160Aug 1, 2002Aug 1, 2008Jan 29, 20091 Canada
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Study Endpoints
Primary Endpoints
disease specific quality of life comparing the 2 groups at 2 years using several shoulder function rating scales.
the Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
the Constant Score
American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment form.
Short Form-12
Secondary Endpoints
the evaluation of radiolucent lines indicative of implant loosening
the incidence of revision surgery complications
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Cemented Humeral StemPROCEDURE -
Uncemented Humeral StemPROCEDURE -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Primary osteoarthritis of the shoulder of grade III or higher (Kellgren and Lawrence modified for the shoulder 2. Patients who have failed standard conservative management of their shoulder osteoarthritis Exclusion Criteria: 1. Patients with secondary OA resulting from majo...

Countries:Canada
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