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ComPreSs Distal Femoral Replacement System.

Phase 1

Lower Thighbone and Knee Joint Replacement | Unknown | Musculoskeletal |Zimmer Biomet Holdings, Inc.|Last Updated: Jun 22, 2023

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00591812Evaluation of the Compress Distal Femoral Replacement SystemPHASE1 COMPLETED 26Apr 1, 2000May 1, 2009Jun 22, 20231 United States
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
1 - ComPreSs systemEXPERIMENTAL -
Interventions
NameTypeDescription
ComPreSs Distal Femoral Replacement System.DEVICEComPreSs system of intramedullary fixation along with the Finn Knee system
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Eligibility Criteria
Age Range10 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients with bone tumors of the distal femur requiring primary bone resection of up to 30 cm with the resection at or below the lesser trochanter. * Patients with prior orthopaedic oncologic conditions requiring revisions of distal femoral replacement devices with a total rep...

Countries:United States
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