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

Not Applicable

Completed

• Conditions: Safety and Performance
• Interventions: Device: REDAPT Sleeved Stem

• Registration Number: NCT05600712
• Lead Sponsor: Foundation for Orthopaedic Research and Education

Brief Summary

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

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 Timeline

• Study Start: 2022-01-11
• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-28
• Study First Posted: 2022-10-31
• Primary Completion: 2024-02-14
• Study Completion: 2024-02-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	REDAPT Sleeved Stem	subjects who have redapt sleeved stem implant

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Foundation for Orthopaedic Research and Education; 🇺🇸 Tampa, Florida, United States