Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty with Standard Instrumentation and Technique
- Conditions
- arthritisdamaged hip10023213
- Registration Number
- NL-OMON50733
- Lead Sponsor
- Medical Device Business Services, Inc. (DePuy Synthes)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 54
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.
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is acetabular cup position success at 6 weeks (12-week can<br /><br>be used if available and the 6-week data is not available) postoperative. It is<br /><br>a composite endpoint; in order for an individual cup position to be considered<br /><br>successful, the cup*s placement must satisfy all of the following criteria at 6<br /><br>weeks:<br /><br>1. Inclination Success: within 10 degrees of the planned inclination<br /><br>2. Version Success: within 10 degrees of the planned anteversion</p><br>
- Secondary Outcome Measures
Name Time Method