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Completed

NCT Number: NCT05600712

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

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

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Key information

Conditions

Safety and Performance

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foundation for Orthopaedic Research and Education

Tampa, Florida, 33607, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

REDAPT Sleeved Stem

Device

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

Primary outcomes

  1. Harris HIp Score (HHS)

    Time frame: 2 years

    measures pain, function, absence of deformity and range of motion after hip surgery. This is performed by a qualified health care provider. The higher the score, the better the outcome.

  2. Hip Disablity and Osterarthritis Outcome Score (HOOS)

    Time frame: 2 year

    Scoring from 0-100 with 0 indicating the worst possible hip symptoms and 100 indicating no symptoms. This tool assesses patients opinion of their hip and associated problems, evaluate symptoms and functional limitations. There are 40 items assessing 5 subscales of: Pain, symptoms, activities of daily living (ADL), function in sport and recreation and Hip related quality of life.

  3. HOOS Jr.

    Time frame: 2 year

    Scoring from 0-100 with 0 indicating the worst possible hip symptoms and 100 indicating no symptoms. This tool assesses patients opinion of their hip and associated problems, evaluate symptoms and functional limitations. this version is shortened to 6 questions assessing function, pain and quality of life.

Sponsors and collaborators

Lead sponsor

Foundation for Orthopaedic Research and Education

Other

Collaborators

  • Smith & Nephew, Inc.

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2022
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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