Anterior Advantage With KINCISE

Study Purpose

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.#46; without KINCISE. Follow-up will continue through 24 weeks post-op.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 21 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04191733
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

DePuy Orthopaedics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Rheumatoid Arthritis, Post Traumatic Arthritis
Additional Details

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.#46; when KINCISE is not used.
  • - Non-inferiority of the percent of subjects with optimal acetabular cup abduction angle when KINCISE is used vs.#46; when KINCISE is not used.
  • - Non-inferiority of the percent of subjects with optimal acetabular cup version angle when KINCISE is used vs.#46; 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 - Complications (including a specific summary of complications within 90 days post-surgery)

Arms & Interventions

Arms

Experimental: Anterior Approach with KINCISE

Anterior Approach THA using KINCISE(TM) Surgical Automated System

Active Comparator: Anterior Approach without KINCISE

Anterior Approach THA with a mallet (without KINCISE)

Interventions

Device: - KINCISE(TM) Surgical Automated System

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Colorado Joint Replacement, Denver, Colorado

Status

Recruiting

Address

Colorado Joint Replacement

Denver, Colorado, 80210

Capital Region Orthopaedic Group, Albany, New York

Status

Not yet recruiting

Address

Capital Region Orthopaedic Group

Albany, New York, 12208

Hospital for Special Surgery, New York, New York

Status

Not yet recruiting

Address

Hospital for Special Surgery

New York, New York, 10021

Columbia University Medical Center, New York, New York

Status

Not yet recruiting

Address

Columbia University Medical Center

New York, New York, 10032

Carolina Orthopaedic & Sports Medicine, Gastonia, North Carolina

Status

Recruiting

Address

Carolina Orthopaedic & Sports Medicine

Gastonia, North Carolina, 28054

Cleveland Clinic, Cleveland, Ohio

Status

Not yet recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Southern Joint Replacement Institute, Nashville, Tennessee

Status

Recruiting

Address

Southern Joint Replacement Institute

Nashville, Tennessee, 37203

Texas Institute for Hip and Knee Surgery, Austin, Texas

Status

Recruiting

Address

Texas Institute for Hip and Knee Surgery

Austin, Texas, 78751

W.B. Carrell Memorial Clinic, Dallas, Texas

Status

Recruiting

Address

W.B. Carrell Memorial Clinic

Dallas, Texas, 75231