Actis Total Hip System 2 Year Follow-up

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
DePuy Orthopaedics
Study ID
NCT02783274
Status
Completed

Conditions

  • Acute Traumatic Fracture of the Femoral Head or Neck
  • Avascular Necrosis of the Femoral Head
  • Certain Cases of Ankylosis
  • Certain High Sub-Capital & Femoral Neck Fractures in Elderly
  • Congenital Hip Dysplasia
  • Non-union of Femoral Neck Fractures
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Traumatic Arthritis

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Actis Total Hip System — DEVICE
    Total Hip Replacement and Hemi-hip Replacement

Study Details

Two-year (2 year) information regarding the performance of the commercially available Actis™ Total Hip System in order to obtain and evaluate the clinical outcomes on a series of cementless primary total hip arthroplasty (THA) and hemi-hip arthroplasty procedures using clinical, radiographic and device and procedure related adverse event assessments.

Key Dates

Start date
Jul 1, 2016
Status verified
Aug 2025
Primary completion
Mar 13, 2024
Completion
Mar 13, 2024

Study Design

Enrollment
266 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Actis Total Hip System
    The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement

Primary Outcome Measure

Harris Hip Score- THA Subjects Per Protocol at 2 Years [ Time Frame: 2 Years ]

Locations (9)

FacilityCityStateZIPSite coordinators
-LouisvilleKentucky40241-
-BostonMassachusetts--
-RochesterMinnesota--
-LebanonNew Hampshire--
-New YorkNew York--
-CharlotteNorth Carolina--
-PhiladelphiaPennsylvania--
-AustinTexas--
-RentonWashington--

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