A Retro/Prospective Multi-Centre Data Capture on REDAPT Sleeved Stem

Foundation for Orthopaedic Research and Education

Status: Completed

Conditions: Safety and Performance

Treatments: Device: REDAPT Sleeved Stem

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05600712

FORESN2

Details and patient eligibility

About

Retro/Prospective study to collect 2 year follow-up on REDAPT sleeved stem.

Full description

The purpose of this study is to assess performance and safety of the Smith & Nephew REDAPT Sleeved Stem by collecting retrospective 2 year post-op with PROMs or prospective 2 year post-op with PROMs.

Enrollment: 45 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Primary and revision surgery for hip degenerative joint disease including osteoarthritis, avascular necrosis, and traumatic arthritis.
• Rheumatoid arthritis, congenital dysplasia, femoral neck fracture, trochanteric fractures of the proximal femur with head involvement, and fracture-dislocation of the hip.

Exclusion criteria

• Conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriate size implant (blood supply limitations, osteoporosis/metabolic disorders, infections)
• Mental or neurological conditions impairing or precluding cooperation with post-operative protocols and proper response to PROMs.
• Skeletal immaturity.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

single arm

Other group

Description:

subjects who have redapt sleeved stem implant

Treatment:

Device: REDAPT Sleeved Stem