INHANCE Stemless Reverse Shoulder IDE

Part of paid clinical trials in Atlantis, Florida.

Sponsor
DePuy Orthopaedics
Study ID
NCT06323980
Status
Recruiting
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Conditions

  • Arthroplasty
  • Replacement
  • Shoulder

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Reverse Total Shoulder — DEVICE
    Uncemented Reverse Total Shoulder

Study Details

2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.

Key Dates

First listed
Mar 21, 2024
Start date
Mar 4, 2025
Status verified
Aug 2026
Primary completion
Nov 10, 2027
Completion
Oct 30, 2028

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: INHANCE Stemless Reverse
    INHANCE(TM) Stemless Reverse Total Shoulder
  • Active Comparator: INHANCE Stemmed Reverse
    INHANCE(TM) Stemmed Reverse Total Shoulder

Primary Outcome Measure

Constant Murley Score (CMS) [ Time Frame: Pre-op, 2 years ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Orthopedic Center of Palm Beach CountyAtlantisFlorida33462-
Boston Bone & Joint Institute BBJI Formerly BSSCWalthamMassachusetts02451-
Trinity Health Grand RapidsGrand RapidsMichigan49503-
Missouri Orthopaedic Institute (MOI)ColumbiaMissouri65201-
OrthoCarolina Research Institute CharlotteCharlotteNorth Carolina28207-
Duke Orthopaedics of RaleighRaleighNorth Carolina27609-
Crystal Clinic Orthopaedic CenterAkronOhio44333-
Lindner Research CenterCincinnatiOhio45219-
The Cleveland Clinic FoundationClevelandOhio44195-
Slocum Center for Orthopaedics and Sports MedicineEugeneOregon97401-
St. Luke's University Health NetworkBethlehemPennsylvania18015-
Rothman Orthopaedics InstitutePhiladelphiaPennsylvania19107-
MTBJ a division of Tennessee Orthaepedic AllianceColumbiaTennessee38401-
University of UtahSalt Lake CityUtah84108-
Mary Washington Orthopedics in affiliation with FOAFredericksburgVirginia22408-

Find similar trials in Atlantis, FL

By research site
Orthopedic Center of Palm Beach County· Atlantis, FLBoston Bone & Joint Institute BBJI Formerly BSSC· Waltham, MATrinity Health Grand Rapids· Grand Rapids, MIMissouri Orthopaedic Institute (MOI)· Columbia, MOOrthoCarolina Research Institute Charlotte· Charlotte, NCDuke Orthopaedics of Raleigh· Raleigh, NC

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