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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-11

Study Completion Date

2024-02-14

Brief Summary

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

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Detailed Description

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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.

Conditions

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Safety and Performance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants who have been implanted with REDAPT Sleeved Stem

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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single arm

subjects who have redapt sleeved stem implant

Group Type OTHER

REDAPT Sleeved Stem

Intervention Type DEVICE

The REDAPT Sleeved Stem is designed to provide secondary proximal support to the distal fixation and enhance implant stability.

Interventions

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REDAPT Sleeved Stem

The REDAPT Sleeved Stem is designed to provide secondary proximal support to the distal fixation and enhance implant stability.

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes