Anterior Advantage With KINCISE
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Anterior Approach with KINCISE Anterior Approach THA using KINCISE(TM) Surgical Automated System |
Device: KINCISE(TM) Surgical Automated System
Uncemented Total Hip Arthroplasty via Anterior Approach with and without the KINCISE(TM) Surgical Automated System
|
| Active Comparator: Anterior Approach without KINCISE Anterior Approach THA with a mallet (without KINCISE) |
Device: KINCISE(TM) Surgical Automated System
Uncemented Total Hip Arthroplasty via Anterior Approach with and without the KINCISE(TM) Surgical Automated System
|
Outcome Measures
Primary Outcome Measures
- Femoral Broach Time [Operative]
The primary endpoint analysis is to demonstrate that femoral broaching time (in minutes) with KINCISE is non-inferior to femoral broaching time with manual instruments (not using KINCISE) under a non-inferiority margin of 1.25 minutes.
Secondary Outcome Measures
- Skin-to-skin Time [Operative]
A non-inferiority test of skin-to-skin OR time will be conducted with a non-inferiority margin of 3.75 minutes, using a 2-sample t-test
- Cup Abduction Angle [6 weeks post-op]
A non-inferiority test of the percent of subjects with acetabular cup abduction angle within +/- 10 degrees of plan under a NI margin of 10%
- Cup Version Angle [6 weeks post-op]
A non-inferiority test of the percent of subjects with acetabular cup version angle within +/- 10 degrees of plan under a NI margin of 10%
- Harris Hip Score [Baseline (pre-op), 6 and 24 weeks]
Harris Hip Score (HHS) and HHS change from preoperative baseline
- Forgotten Joint Score (FJS-12) [6 and 24 weeks]
Forgotten Joint Score (FJS) and FJS change from 6-week postoperative baseline
- Pain (Patient Questionnaire) [Baseline (pre-op), 6 and 24 weeks]
Pain (Groin, Thigh, and Buttock); determined via patient questionnaire
- Patient Satisfaction (Patient Questionnaire) [Baseline (pre-op), 6 and 24 weeks]
Assessment of expected satisfaction pre-operatively and post-op patient satisfaction at 6 and 24 weeks post-op
- Functional Outcomes [Baseline (pre-op), 6 and 24 weeks]
Post-op time when functional activities can be accomplished (return to work; self-care; etc.)
- Length of Stay [Operative/Discharge (Day 0 to day of discharge)]
Length of hospital stay after index THA
- Re-hospitalizations [24 weeks]
Re-hospitalizations during the study (including a specific summary of re-hospitalizations within 90 days)
- Narcotic Drug Use [24 weeks]
Narcotic drug usage throughout the study. This will be reported by the participant.
- Complications [24 weeks]
Complications (including a specific summary of complications within 90 days post-surgery)
- Acetabular Cup Position [6 and 24 weeks]
Measure (in degrees) of acetabular cup inclination and version
- Acetabular Cup Migration [6 and 24 weeks]
Measure and summary of any reports of acetabular cup migration
- Acetabular Cup Radiographic Outcomes [6 and 24 weeks]
Measure and summary of any reports of acetabular cup radiolucency, osteolysis, and sclerotic lines
- Femoral Stem Position [6 and 24 weeks]
Measure and summary of femoral stem position, tilt and subsidence
- Femoral Stem Radiographic Outcomes [6 and 24 weeks]
Measure and summary of any reported femoral stem radiolucency, osteolysis, sclerotic lines
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Orthopedic Specialty Center of Northern California | Roseville | California | United States | 95678 |
| 2 | Colorado Joint Replacement | Denver | Colorado | United States | 80210 |
| 3 | Capital Region Orthopaedic Group | Albany | New York | United States | 12208 |
| 4 | Hospital for Special Surgery | New York | New York | United States | 10021 |
| 5 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 6 | Carolina Orthopaedic & Sports Medicine | Gastonia | North Carolina | United States | 28054 |
| 7 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 8 | Southern Joint Replacement Institute | Nashville | Tennessee | United States | 37203 |
| 9 | Texas Institute for Hip and Knee Surgery | Austin | Texas | United States | 78751 |
| 10 | W.B. Carrell Memorial Clinic | Dallas | Texas | United States | 75231 |
| 11 | North Texas Medical Research Institute | Dallas | Texas | United States | 75254 |
| 12 | Jordan-Young Institute | Virginia Beach | Virginia | United States | 23462 |
Sponsors and Collaborators
- DePuy Orthopaedics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DSJ_2019_03