Clinical trial NCT03072459: A Retrospective Study of the Navio Robotic-assisted Surgical System
Official title: A Retrospective Study of the Navio™ Robotic-assisted Surgical System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Robotics
Knee Replacement
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-07
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred twenty-eight (128) subjects, including 10% inflation to allow for attrition

Brief summary: A retrospective, multi-center, cohort study with prospective follow-up and comparison to historical control

Detailed description: Subjects who had previously received the Navio robotic-assisted surgical system for unilateral knee replacement (UKR) were assessed to determine the 2-year safety and effectiveness of the Navio system.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects ≥ 18 years old (at the time of surgery) who have undergone Navio System-assisted UKR at least 2 years prior to enrollment. This includes UKR procedures with all Unicondylar Knee cemented implant designs.
2. Subject had a primary diagnosis of unicompartmental, non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis, required correction of functional deformity, or required treatment of fractures that were unmanageable using other techniques.

Exclusion Criteria:

1. Subject received the Navio System-assisted UKR on the index joint as a revision for a previously failed UKR.
2. Subject, in the opinion of the Investigator, had advanced osteoarthritis or joint disease at the time of surgery and was better suited for Total Knee Arthroplasty (TKA).
3. Subject, in the opinion of the Investigator, had a neuromuscular disorder that prohibited control of the index joint.
4. Subject, in the opinion of the Investigator, was morbidly obese.
5. Subject, in the opinion of the Investigator, was contraindicated for UKR.
6. Subject (prospective subjects only), in the opinion of the Investigator, has an emotional or neurological condition including mental illness, mental retardation, drug or alcohol abuse.
7. Subject (prospective subjects only) is a prisoner.

Primary outcomes:
measure: Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship
timeFrame: Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively
Secondary outcomes:
measure: Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
timeFrame: Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively
measure: Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
timeFrame: Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively
measure: Preoperative Evaluation of Efficacy Based on Radiographic Findings
timeFrame: Preoperative (Baseline)
measure: Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
timeFrame: 6 months postoperatively
measure: Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
timeFrame: 12 months postoperatively
measure: Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
timeFrame: 18 months postoperatively
measure: Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
timeFrame: 24 months postoperatively
measure: Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
timeFrame: 30 months postoperatively
measure: Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
timeFrame: 36 months postoperatively
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hedley Orthopedics
state: Arizona
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Battle Creek
country: United States
facility: Bronson Orthopedic Specialists
state: Michigan
city: New Albany
country: United States
facility: OrthoNeuro New Albany
state: Ohio
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
affiliation: Smith & Nephew, Inc.
name: Beate Hanson, MD, PhD
role: STUDY_DIRECTOR
References: