Safety and Performance
Conditions
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.
Interventions
DEVICEREDAPT Sleeved Stem
The REDAPT Sleeved Stem is designed to provide secondary proximal support to the distal fixation and enhance implant stability.
Sponsors
Smith & Nephew, Inc.
Foundation for Orthopaedic Research and Education
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Participants who have been implanted with REDAPT Sleeved Stem
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed