Clinical trial NCT04191733: Anterior Advantage With KINCISE
Official title: Prospective, Randomized, Multi-center Post-Market Study of Anterior Advantage Surgical Approach in Total Hip Arthroplasty With and Without the KINCISE™ Surgical Automated System.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Rheumatoid Arthritis
Post Traumatic Arthritis
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2019-12-10
Enrollment: 250
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 Block Randomization
Primary purpose: TREATMENT

Brief summary: This is a post-market prospective, 1:1 randomized, multicenter non-inferiority study to compare the femoral broaching time for THA with the Anterior Advantage approach with KINCISE vs. without KINCISE. Follow-up will continue through 24 weeks post-op.

Detailed description: The primary endpoint is femoral broaching time (in minutes), which is collected intraoperatively. The primary objective is to demonstrate that femoral broaching time with KINCISE is non-inferior to femoral broaching time with manual instruments (not using KINCISE) when used in THA with Anterior Advantage.

Note: If non-inferiority is successfully demonstrated, then the study will be deemed to be successful, and a test for superiority of femoral broaching time will be conducted.

If the primary endpoint analysis successfully demonstrates non-inferiority of femoral broaching time, then the following three secondary objectives will be assessed with formal hypotheses, in order, under a gatekeeping strategy:

* Non-inferiority of skin-to-skin OR time when KINCISE is used vs. when KINCISE is not used.
* Non-inferiority of the percent of subjects with optimal acetabular cup abduction angle when KINCISE is used vs. when KINCISE is not used.
* Non-inferiority of the percent of subjects with optimal acetabular cup version angle when KINCISE is used vs. when KINCISE is not used.

In addition, the following secondary endpoints do not have prospectively planned hypotheses; these will be summarized for both treatment groups:

* Harris Hip Score (HHS) and HHS change from preoperative baseline
* Forgotten Joint Score (FJS) and FJS change from 6-week postoperative baseline
* EQ-5D-5L and changes in these assessments from preoperative baseline
* Pain (Groin, Thigh, and Buttock)
* Patient Satisfaction
* Post-op time when functional activities can be accomplished (return to work, self-care, etc.)
* Radiographic Outcomes (based upon AP Hip, AP Pelvis, and Lateral)
* Length of hospital stay after index THA
* Re-hospitalizations during the study (including a specific summary of re-hospitalizations within 90 days)
* Narcotic drug usage throughout the study (participant reported)
* Complications (including a specific summary of complications within 90 days post-surgery)

Eligibility criteria: Inclusion Criteria:

1. The patient is undergoing a standard of care primary cementless hip replacement with the Pinnacle cup and a Corail or Actis stem via the Anterior Advantage approach. All devices are to be used according to the approved indications.
2. Individuals who are able to speak, read, and comprehend the Institutional Review Board approved 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.
3. Individuals who are willing and able to complete follow-up visits and questionnaires as specified by the study protocol.
4. Individuals who are not bedridden per the discretion of the investigator (The intent of "not bedridden" means a permanent situation, not a temporary situation as in a hip fracture or trauma case).
5. 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 3 months prior to surgery date, contralateral hip is already enrolled in the study, or simultaneous or staged hip replacement is planned
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 physical or psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.

Primary outcomes:
measure: Mean Femoral Broach Time
timeFrame: Day 0 (operative day)
Secondary outcomes:
measure: Skin-to-skin Time
timeFrame: Day 0 (operative day)
measure: Number of Participants With Optimal Acetabular Cup Abduction Angle at Week 6
timeFrame: At Week 6 (post operative)
measure: Number of Participants With Optimal Acetabular Cup Version Angle at Week 6
timeFrame: At Week 6 (post operative)
measure: Change From Pre-operative Baseline in Harris Hip Score (HHS) at Weeks 6 and 24
timeFrame: Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative
measure: Change From 6-week Post-surgery in Forgotten Joint Score (FJS-12) at Week 24
timeFrame: 6-week post-operative to 24 weeks post-operatively
measure: Change From Pre-operative Baseline in European Quality of Life (EuroQol)-5 Dimension-5 Level (EQ-5D-5L) Heath State Index Total Score at Weeks 6 and 24
timeFrame: Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative
measure: Change From Pre-operative Baseline in EQ-5D-5L Visual Analog Scale (VAS) Total Score at Weeks 6 and 24
timeFrame: Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative
measure: Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24
timeFrame: Weeks 6 and 24 (post-operative)
measure: Number of Participants With Post-operative Satisfaction With the Procedure at Weeks 6 and 24
timeFrame: Weeks 6 and 24 (post-operative)
measure: Number of Participants With Post-operative Functional Recovery at Week 6
timeFrame: Week 6 (post-operative)
measure: Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur
timeFrame: Weeks 6 and 24 (post-operative)
measure: Number of Participants With Radiographic Outcomes: Femoral Stem Position
timeFrame: Weeks 6 and 24 (post-operative)
measure: Number of Participants With Radiographic Outcomes: Device/Anatomy Condition
timeFrame: Weeks 6 and 24 (post-operative)
measure: Number of Participants With Radiographic Outcomes: Heterotopic Ossification
timeFrame: Weeks 6 and 24 (post-operative)
measure: Radiographic Outcomes: Assessment of Acetabular Cup Version (Hip) and Acetabular Cup Inclination
timeFrame: Weeks 6 and 24 (post-operative)
measure: Length of Hospital Stay After Index Total Hip Arthroplasty (THA)
timeFrame: From operative day (Day 0) to date of discharge (any time from Day 0 to Day 5)
measure: Number of Participants With Re-hospitalization During the Study
timeFrame: Day 0 (operative day) to Day 90 (post-operative)
measure: Number of Participants With Narcotic Pain Medication Usage
timeFrame: From post operation (Day 0) to Week 24
measure: Number of Participants With Post-operative Complications
timeFrame: Day 0 (operative day) up to Week 24
Other outcomes:
Locations:
city: Roseville
country: United States
facility: The Orthopedic Specialty Center of Northern California
state: California
city: Denver
country: United States
facility: Colorado Joint Replacement
state: Colorado
city: Albany
country: United States
facility: Capital Region Orthopaedic Group
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Gastonia
country: United States
facility: Carolina Orthopaedic & Sports Medicine
state: North Carolina
city: Nashville
country: United States
facility: Southern Joint Replacement Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Institute for Hip and Knee Surgery
state: Texas
city: Dallas
country: United States
facility: W.B. Carrell Memorial Clinic
state: Texas
city: Dallas
country: United States
facility: North Texas Medical Research Institute
state: Texas
city: Virginia Beach
country: United States
facility: Jordan-Young Institute
state: Virginia
Study officials:
References: