Anterior Advantage With KINCISE

Study Overview
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Brief Summary
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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
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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)

Official Title
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Prospective, Randomized, Multi-center Post-Market Study of Anterior Advantage Surgical Approach in Total Hip Arthroplasty With and Without the KINCISE™ Surgical Automated System.

Conditions
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Osteoarthritis, Rheumatoid Arthritis, Post Traumatic Arthritis

Intervention / Treatment
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* Device: KINCISE(TM) Surgical Automated System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 Block Randomization
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anterior Approach with KINCISE<br>Anterior Approach THA using KINCISE(TM) Surgical Automated System | Device: KINCISE(TM) Surgical Automated System<br>* Uncemented Total Hip Arthroplasty via Anterior Approach with and without the KINCISE(TM) Surgical Automated System<br>|
| Active Comparator: Anterior Approach without KINCISE<br>Anterior Approach THA with a mallet (without KINCISE) | Device: KINCISE(TM) Surgical Automated System<br>* Uncemented Total Hip Arthroplasty via Anterior Approach with and without the KINCISE(TM) Surgical Automated System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin-to-skin Time | Skin-to-skin is the time (in minutes) duration of the surgery procedure. | Day 0 (operative day) | 
| Number of Participants With Optimal Acetabular Cup Abduction Angle at Week 6 | Number of participants with optimal acetabular cup (a socket of the hip joint) abduction angle (movement of the leg away from the midline of the body) within +/- 10 degree of plan at Week 6 was reported. | At Week 6 (post operative) | 
| Number of Participants With Optimal Acetabular Cup Version Angle at Week 6 | Number of participants with optimal acetabular cup (a socket of the hip joint) version angle (rotation of leg in hip joint) within +/- 10 degrees of plan at Week 6 was reported. | At Week 6 (post operative) | 
| Change From Pre-operative Baseline in Harris Hip Score (HHS) at Weeks 6 and 24 | The HHS was developed for the assessment of the results of hip surgery. HHS was intended to evaluate various hip disabilities and methods of treatment in an adult population. It consisted of 10 items covering four domains: pain (1 item, 0-44 points), function ( 7 items [limb, support, distance walked, stairs, socks/shoes, sitting and public transportation], 0-47 points), deformity (1 item, 4 points) and range of hip motion (1 items, 5 points). HHS total score was the sum of 10 items scores and ranged from 0 (worse disability) to 100 (less disability). The higher score indicated better outcome for the participant. The scores were interpreted as follows: < 70 = poor, 70-79 = fair, 80-89 = good and 90-100 = excellent. Day 0 was the operative day. | 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 | The FJS was a 12 question form that asks the participants their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Response to each question was individually scored (0 to 4, where 0=never, 1=almost never, 2=seldom, 3=sometimes and 4=mostly) and summed to create a raw composite score that was normalized to a range of 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the artificial joint in everyday life). | 6-week post-operative to 24 weeks post-operatively | 
| 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 | EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D-5L dimensions were scored using a utility-weighted algorithm to derive an EQ-5D-5L health status index score between 0 (death) to 100 (full health). Higher score indicated better QoL. | Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative | 
| Change From Pre-operative Baseline in EQ-5D-5L Visual Analog Scale (VAS) Total Score at Weeks 6 and 24 | EQ-5D-5L was a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status. | Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative | 
| Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 | Number of participants with pain (Groin, and Buttock) at Weeks 6 and 24 was reported. Participant's groin pain and buttock pain was reported either as none, mild, moderate, or severe. | Weeks 6 and 24 (post-operative) | 
| Number of Participants With Post-operative Satisfaction With the Procedure at Weeks 6 and 24 | Number of participants with post-operative satisfaction with the procedure at Weeks 6 and 24 was reported. Participants were asked a question that How satisfied do you anticipate you will be with this procedure? and participant responded on a 5-point scale (1=extremely satisfied, 2=very satisfied, 3=moderately satisfied, 4=slightly satisfied, 5=not at all satisfied). Higher score indicated low post-operative satisfaction. | Weeks 6 and 24 (post-operative) | 
| Number of Participants With Post-operative Functional Recovery at Week 6 | Participants were asked the following questions: Can you walk without an aid?, Do you drive?, Can you perform basic activities of daily living without assistance?, Can you perform light household duties?, Can you perform moderate to heavy household duties?, Can you go up and down a flight of stairs using a handrail?, Can you put on socks/stockings without someone's assistance?, Can you bend down to pick up an object on the floor?, Can you stand up from a chair without assistance?, Can you participate in leisure recreational activities?, Do you work? and When were you first able to accomplish the primary goal you identified after surgery?. Participants were asked to respond either as yes or No, because of study hip. Number of participants who reported response as yes at Week 6 were reported in this outcome measure. | Week 6 (post-operative) | 
| Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur | Number of participants with radiographic outcomes (acetabular cup migration, acetabular cup radiolucency, acetabular cup progressive radiolucency, acetabular cup osteolysis, acetabular cup sclerotic lines, acetabular cup porous coating integrity, femoral stem subsidence, femoral stem radiolucency, femoral stem osteolysis, calcar resorption, calcar fracture, femoral stem tilt and femoral stem porous coating integrity) were reported. In this outcome measure, only those timepoints in which participants had data were reported. In this outcome measure, each radiographic outcome assessment was reported either as present or absent in the analyzed participants. | Weeks 6 and 24 (post-operative) | 
| Number of Participants With Radiographic Outcomes: Femoral Stem Position | Number of participants with radiographic outcome (femoral stem position) were reported. Femoral stem position was assessed as neutral, varus and valgus. | Weeks 6 and 24 (post-operative) | 
| Number of Participants With Radiographic Outcomes: Device/Anatomy Condition | Number of participants with radiographic outcome (device/anatomy condition) were reported. Assessments were reported as intact or not intact. | Weeks 6 and 24 (post-operative) | 
| Number of Participants With Radiographic Outcomes: Heterotopic Ossification | Number of participants with radiographic outcome (heterotopic ossification) were reported. Ossification is defined as formation of extraskeletal bone in muscle and soft tissues. Heterotopic ossification is the presence of bone in soft tissue where bone normally does not exist. Heterotopic ossification was classified as Class 0, I, II, III and IV where Class 0 indicates no evidence heterotopic bone formation, Class I indicates islands of bone within the soft tissue about the hip, Class II indicates bone spurs from the pelvis or proximal end of the femur, leaving at least a centimeter (cm) between opposing bone surfaces, Class III indicates bone spurs from the pelvis or proximal end of the femur, reducing the space between opposing bone surfaces to less than 1 cm, and Class IV indicates apparent bone ankylosis of the hip. | Weeks 6 and 24 (post-operative) | 
| Radiographic Outcomes: Assessment of Acetabular Cup Version (Hip) and Acetabular Cup Inclination | Radiographic outcome was assessed on acetabular cup version (hip) and acetabular cup inclination and reported in this outcome measure. | Weeks 6 and 24 (post-operative) | 
| Length of Hospital Stay After Index Total Hip Arthroplasty (THA) | Length of hospital stay (in days) after index THA was calculated from date of discharge minus date of surgery. | From operative day (Day 0) to date of discharge (any time from Day 0 to Day 5) | 
| Number of Participants With Re-hospitalization During the Study | Number of participants with re-hospitalizations during the study was reported. | Day 0 (operative day) to Day 90 (post-operative) | 
| Number of Participants With Narcotic Pain Medication Usage | Number of participants who received any narcotic pain medication to manage study hip pain was reported. | From post operation (Day 0) to Week 24 | 
| Number of Participants With Post-operative Complications | Number of participants who experienced post-operative complication was reported. | Day 0 (operative day) up to Week 24 |