Clinical trial NCT03189303: Cup Position in THA With Standard Instruments
Official title: Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Standard Instrumentation and Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis; Rheumatoid Arthritis; Post Traumatic Arthritis
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2017-06-16
Enrollment: 183
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who the investigator deems to be a candidate for a primary total hip arthroplasty (THA) using the study devices (Pinnacle cup with a Corail or Summit stem) in a primary uncemented THA.

Brief summary: Prospective, global, multicenter study to assess cup position in THA. After written informed consent has been obtained, study evaluations will be collected from the pre-op clinic visit, the operative visit (including discharge), and 6 and 12 weeks postoperatively.

Detailed description: This is a global, prospective, multi-center study with a planned analysis of a minimum of 176 Subjects. Up to 15 study sites will participate in this study. The primary and secondary endpoints are as follows:

Primary endpoint:

The primary endpoint is acetabular cup position success at 6 weeks postoperatively. Success is defined as cup inclination and version within 10 degrees of the plan.

Secondary endpoints:

1. Inclination success (as defined for the primary endpoint)
2. Version success (as defined for the primary endpoint)
3. 90-day complication rates
4. Change from preoperative baseline for the Harris Hip Score
5. Radiographic Outcomes (based upon: AP Hip, AP Pelvis, and Modified Lauenstein Lateral)
6. Change from preoperative baseline for the EQ-5D-5L (health state, EQ-VAS, and index value, if applicable)
7. Change from 6 week baseline for the Forgotten Joint Score

Eligibility 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:

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.

Primary outcomes:
measure: Composite success of cup inclination and cup version.
timeFrame: 6 weeks
Secondary outcomes:
measure: Inclination success
timeFrame: 6 weeks
measure: Version success
timeFrame: 6 weeks
measure: 90 day postoperative complication rates
timeFrame: 90 days postoperative
measure: Harris Hip Score
timeFrame: Baseline and 6 and 12 weeks postoperative
measure: Forgotten Joint Score
timeFrame: 6 and 12 weeks postoperative
measure: EQ-5D-5L dimension score
timeFrame: Baseline and 6 and 12 weeks postoperative
measure: EQ-VAS score (subscore of EQ-5D-5L)
timeFrame: Baseline and 6 and 12 weeks postoperative
measure: EQ-5D-5L index value (if applicable)
timeFrame: Baseline and 6 and 12 weeks postoperative
measure: Radiographic Outcomes
timeFrame: Baseline and 6 and 12 weeks postoperative
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Orthopaedic Associates of Michigan
state: Michigan
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Gastonia
country: United States
facility: Carolina Orthopaedic and Sports Medicine Center
state: North Carolina
city: Newark
country: United States
facility: Orthopedic Specialists and Sports Medicine
state: Ohio
city: Charleston
country: United States
facility: Lowcountry Orthopaedics & Sports Medicine
state: South Carolina
city: Milan
country: Italy
facility: Istituto Orthopedico Galeazzi IRCCS
city: Bergen op Zoom
country: Netherlands
facility: Bravis Hospital
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Hospital
city: Aberdeen
country: United Kingdom
facility: Woodend Hospital
state: Scotland
city: Rhyl
country: United Kingdom
facility: Glan Clwyd Hospital
state: Wales
Study officials:
References: