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

NCT05600712 | Completed DMC FDA Device

• 1 other identifier: FORESN2
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety and Performance

Outcome Measures

Primary Outcomes (3)

• Harris HIp Score (HHS)

  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)

  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.

  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

Study Arms (1)

single arm

OTHER

subjects who have redapt sleeved stem implant

Device: REDAPT Sleeved Stem

Interventions

REDAPT Sleeved Stem DEVICE

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

single arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Foundation for Orthopaedic Research and Education

Tampa, Florida, 33607, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants who have been implanted with REDAPT Sleeved Stem

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 31, 2022
• Study Start: January 11, 2022
• Primary Completion: February 14, 2024
• Study Completion: February 14, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)