Study Stopped
Sponsor terminated study early. Data collection was sufficient to adequately assess primary endpoint.
Anterior Advantage With KINCISE
Prospective, Randomized, Multi-center Post-Market Study of Anterior Advantage Surgical Approach in Total Hip Arthroplasty With and Without the KINCISE™ Surgical Automated System.
1 other identifier
interventional
250
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
Typical duration for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2019
CompletedFirst Posted
Study publicly available on registry
December 10, 2019
CompletedStudy Start
First participant enrolled
January 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedResults Posted
Study results publicly available
September 15, 2023
CompletedSeptember 15, 2023
September 1, 2023
2.5 years
October 28, 2019
July 13, 2023
September 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Femoral Broach Time
Mean femoral broach time (in minutes) was collected intraoperatively and begun at the time the box osteotome first enters the femoral canal and ended with seating of the final broach trial within the femoral canal.
Day 0 (operative day)
Secondary Outcomes (19)
Skin-to-skin Time
Day 0 (operative day)
Number of Participants With Optimal Acetabular Cup Abduction Angle at Week 6
At Week 6 (post operative)
Number of Participants With Optimal Acetabular Cup Version Angle at Week 6
At Week 6 (post operative)
Change From Pre-operative Baseline in Harris Hip Score (HHS) at Weeks 6 and 24
Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative
Change From 6-week Post-surgery in Forgotten Joint Score (FJS-12) at Week 24
6-week post-operative to 24 weeks post-operatively
- +14 more secondary outcomes
Study Arms (2)
Anterior Approach with KINCISE
EXPERIMENTALAnterior Approach THA using KINCISE(TM) Surgical Automated System
Anterior Approach without KINCISE
ACTIVE COMPARATORAnterior Approach THA with a mallet (without KINCISE)
Interventions
Uncemented Total Hip Arthroplasty via Anterior Approach with and without the KINCISE(TM) Surgical Automated System
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- Individuals who are willing and able to complete follow-up visits and questionnaires as specified by the study protocol.
- 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).
- Individuals who are a minimum age of 21 years at the time of consent.
You may not qualify if:
- Active local or systemic infection.
- Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
- 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).
- Charcot's or Paget's disease.
- The Subject is a woman who is pregnant or lactating.
- Subject had a contralateral amputation.
- Previous partial hip replacement in affected hip.
- Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
- 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
- Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- 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.
- Subject has a medical condition with less than 2 years of life expectancy.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
The Orthopedic Specialty Center of Northern California
Roseville, California, 95678, United States
Colorado Joint Replacement
Denver, Colorado, 80210, United States
Capital Region Orthopaedic Group
Albany, New York, 12208, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Columbia University Medical Center
New York, New York, 10032, United States
Carolina Orthopaedic & Sports Medicine
Gastonia, North Carolina, 28054, United States
Southern Joint Replacement Institute
Nashville, Tennessee, 37203, United States
Texas Institute for Hip and Knee Surgery
Austin, Texas, 78751, United States
W.B. Carrell Memorial Clinic
Dallas, Texas, 75231, United States
North Texas Medical Research Institute
Dallas, Texas, 75254, United States
Jordan-Young Institute
Virginia Beach, Virginia, 23462, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study was terminated early due to business decision and not related to any safety concerns.
Results Point of Contact
- Title
- FRANCHISE MEDICAL DIRECTOR
- Organization
- DePuy Orthopaedics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2019
First Posted
December 10, 2019
Study Start
January 28, 2020
Primary Completion
July 13, 2022
Study Completion
August 31, 2022
Last Updated
September 15, 2023
Results First Posted
September 15, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu/