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

March 13, 2024 updated by: Foundation for Orthopaedic Research and Education
Retro/Prospective study to collect 2 year follow-up on REDAPT sleeved stem.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33607
        • Foundation for Orthopaedic Research and Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: single arm
subjects who have redapt sleeved stem implant
Device: REDAPT Sleeved Stem
The REDAPT Sleeved Stem is designed to provide secondary proximal support to the distal fixation and enhance implant stability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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.
2 year
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.
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation for Orthopaedic Research and Education

Collaborators

Smith & Nephew, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2022

Primary Completion (Actual)

February 14, 2024

Study Completion (Actual)

February 14, 2024

Study Registration Dates

First Submitted

October 25, 2022

First Submitted That Met QC Criteria

October 28, 2022

First Posted (Actual)

October 31, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • FORESN2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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