Anterior Advantage With KINCISE

DePuy Synthes

Status: Terminated

Conditions: Post Traumatic Arthritis; Osteoarthritis; Rheumatoid Arthritis

Treatments: Device: KINCISE(TM) Surgical Automated System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04191733

DSJ_2019_03

Details and patient eligibility

About

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.

Full 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)

Enrollment: 250 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Anterior Approach with KINCISE

Experimental group

Description:

Anterior Approach THA using KINCISE(TM) Surgical Automated System

Treatment:

Device: KINCISE(TM) Surgical Automated System

Anterior Approach without KINCISE

Active Comparator group

Description:

Anterior Approach THA with a mallet (without KINCISE)

Treatment:

Device: KINCISE(TM) Surgical Automated System