Prospective, Randomized, Multi-center Post-Market Study of Anterior Advantage Surgical Approach in Total Hip Arthroplasty With and Without the KINCISE™ Surgical Automated System.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- DePuy Orthopaedics
- Enrollment
- 250
- Locations
- 11
- Primary Endpoint
- Mean Femoral Broach Time
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
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)
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Mean Femoral Broach Time
Time Frame: Day 0 (operative day)
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.
Secondary Outcomes
- Change From 6-week Post-surgery in Forgotten Joint Score (FJS-12) at Week 24(6-week post-operative to 24 weeks post-operatively)
- Skin-to-skin Time(Day 0 (operative day))
- Number of Participants With Optimal Acetabular Cup Version Angle at Week 6(At Week 6 (post operative))
- Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24(Weeks 6 and 24 (post-operative))
- Number of Participants With Radiographic Outcomes: Device/Anatomy Condition(Weeks 6 and 24 (post-operative))
- Length of Hospital Stay After Index Total Hip Arthroplasty (THA)(From operative day (Day 0) to date of discharge (any time from Day 0 to Day 5))
- Number of Participants With Optimal Acetabular Cup Abduction Angle at Week 6(At Week 6 (post operative))
- Change From Pre-operative Baseline in EQ-5D-5L Visual Analog Scale (VAS) Total Score at Weeks 6 and 24(Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative)
- Number of Participants With Post-operative Satisfaction With the Procedure at Weeks 6 and 24(Weeks 6 and 24 (post-operative))
- Number of Participants With Post-operative Functional Recovery at Week 6(Week 6 (post-operative))
- Number of Participants With Radiographic Outcomes: Heterotopic Ossification(Weeks 6 and 24 (post-operative))
- Number of Participants With Re-hospitalization During the Study(Day 0 (operative day) to Day 90 (post-operative))
- Number of Participants With Narcotic Pain Medication Usage(From post operation (Day 0) to Week 24)
- Change From Pre-operative Baseline in Harris Hip Score (HHS) at Weeks 6 and 24(Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative)
- 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(Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative)
- Number of Participants With Radiographic Outcomes: Femoral Stem Position(Weeks 6 and 24 (post-operative))
- Number of Participants With Post-operative Complications(Day 0 (operative day) up to Week 24)
- Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur(Weeks 6 and 24 (post-operative))
- Radiographic Outcomes: Assessment of Acetabular Cup Version (Hip) and Acetabular Cup Inclination(Weeks 6 and 24 (post-operative))