Anterior Advantage With KINCISE

N/ATerminatedNCT04191733

DePuy Orthopaedics250 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

Osteoarthritis Rheumatoid Arthritis Post Traumatic Arthritis

Interventions

KINCISE(TM) Surgical Automated SystemDEVICE

Uncemented Total Hip Arthroplasty via Anterior Approach with and without the KINCISE(TM) Surgical Automated System

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (11)

The Orthopedic Specialty Center of Northern California

Roseville, California, United States

Colorado Joint Replacement

Denver, Colorado, United States

Capital Region Orthopaedic Group

Albany, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Day 0 (operative day)

Secondary Outcomes

Skin-to-skin Time

Skin-to-skin is the time (in minutes) duration of the surgery procedure.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Hospital for Special Surgery

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Carolina Orthopaedic & Sports Medicine

Gastonia, North Carolina, United States

Southern Joint Replacement Institute

Nashville, Tennessee, United States

Texas Institute for Hip and Knee Surgery

Austin, Texas, United States

W.B. Carrell Memorial Clinic

Dallas, Texas, United States

North Texas Medical Research Institute

Dallas, Texas, United States

...and 1 more locations

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.