arthritis damaged hip
Conditions
Interventions
None listed
Sponsors
Medical Device Business Services, Inc. (DePuy Synthes)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) All devices are to be used according to the approved indications 2) The patient is undergoing a standard of care hip replacement with the Pinnacle cup and a Corail, Summit or Actis stem via the posterolateral, anterolateral, or direct lateral approach with the patient in the lateral decubitus position. 3) Individuals who are able to speak, read, and comprehend the Informed Consent Document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of his/her information to DePuy Synthes. 4) Individuals who are willing and able to complete follow-up as specified by the study protocol. 5) Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires (i.e., FJS-12, EQ-5D-5L and Hip Evaluation) as specified by the study protocol. 6) Individuals who are not bedridden. 7) Individuals who are a minimum age of 21 years at the time of consent.
Exclusion criteria
Exclusion criteria: 1) Active local or systemic infection. 2) Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified. 3) Poor bone quality, such as osteoporosis, where, in the surgeon*s opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s). 4) Charcot*s or Paget*s disease. 5) The Subject is a woman who is pregnant or lactating. 6) Subject had a contralateral amputation. 7) Previous partial hip replacement in affected hip. 8) Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months. 9) Contralateral hip was replaced less than 6 months prior to surgery date 10) Subject is currently involved in any personal injury litigation, medical-legal or worker*s compensation claims. 11) Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia. 12) Subject has a medical condition with less than 2 years of life expectancy. 13) Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is acetabular cup position success at 6 weeks (12-week can be used if available and the 6-week data is not available) postoperative. It is a composite endpoint; in order for an individual cup position to be considered successful, the cup*s placement must satisfy all of the following criteria at 6 weeks: 1. Inclination Success: within 10 degrees of the planned inclination 2. Version Success: within 10 degrees of the planned anteversion | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are as follows: * Inclination success (as defined for the primary endpoint) * Version success (as defined for the primary endpoint) * 90-day complication rates * Change from preoperative baseline for the Harris Hip Score * Radiographic Outcomes (based upon: AP Hip, AP Pelvis, and Lateral) * Change from preoperative baseline for the EQ-5D-5L (health state, EQ-VAS, and index value, if applicable) * Change from 6 week baseline for the Forgotten Joint Score Inclination success and version success will be evaluated at 6 and 12 weeks as defined within 10 degrees of the planned inclination and within 10 degrees of the planned version, respectively. In addition, Harris Hip scores and EQ-5D-5L scores will be collected at Pre-Op, 6 and 12 weeks. The Forgotten Joint Score and radiographic outcomes will be collected at 6 and 12 weeks postoperative. Complications include readmission, reoperation, procedure related AEs, and device related AEs. Complication rates will be presented at 90 days post-op. | — |
Countries
Netherlands
Outcome results
None listed