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

Sponsor
Foundation for Orthopaedic Research and Education (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05600712
Collaborator
Smith & Nephew, Inc. (Industry)
45
Enrollment
1
Location
25
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: REDAPT Sleeved Stem
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Participants who have been implanted with REDAPT Sleeved StemParticipants who have been implanted with REDAPT Sleeved Stem
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Retro/Prospective Multi-Centre Data Capture on REDAPT Sleeved Stem
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Harris HIp Score (HHS) [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) [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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Foundation for Orthopaedic Research and Education Tampa Florida United States 33607

Sponsors and Collaborators

  • Foundation for Orthopaedic Research and Education
  • Smith & Nephew, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Foundation for Orthopaedic Research and Education
ClinicalTrials.gov Identifier:
NCT05600712
Other Study ID Numbers:
  • FORESN2
First Posted:
Oct 31, 2022
Last Update Posted:
Nov 2, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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

Study Results

No Results Posted as of Nov 2, 2022