Making Sense Out of Total Knee Sensor Assisted Technology: A Randomized Control Trial

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

Making Sense Out of Total Knee Sensor Assisted Technology: A Randomized Control Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02717299
• Other study ID #: 15-053
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: April 8, 2021

Study information

• Verified date: April 2019
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the patient reported outcome measures of total knee replacement patients who received intra operative sensor guided technique for soft tissue balancing to a group of patients who receive surgeon guided soft tissue balancing.

Description:

This study will compare a group of total knee arthroplasty patients who receive sensor guidance technology for soft tissue balancing intra operatively to a group of patients who receive surgeon guided soft tissue balancing. Patients will be randomized to either the experimental group with the sensor guided technology or the control group which is the surgeon guided technique and current standard of care. All patients will have the sensor placed intra operatively so that measurements can be captured and recorded however, the measurements for the patients who are not in the sensor guided group will not be revealed to the surgeon. The information will be gathered for post enrollment data analysis only. The patients measurements in the sensor guided group will be revealed to the surgeon and the surgeon will use this information in order to help guide soft tissue balancing for optimal alignment intra operatively. Patients will be followed for 1 year post operatively. Patient reported outcomes measures such as KSS, KOOS, PROMIS PF CAT, EQ-5D and UCLA activity will be collected preoperatively and at 3 months, 6 months, and 12 months. Post-operative Likert scale patient satisfaction scores will also be collected. All outcomes will be scored and compared to determine significance.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 78
• Est. completion date: April 8, 2021
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing primary unilateral total knee arthroplasty for osteoarthritis, avascular necrosis, inflammatory arthropathy, or post traumatic arthritis.

• Patients able to understand study intent, and agree to study participation.

• Patients receiving Smith and Nephew Journey II total knee implant system.

Exclusion Criteria:

• Patients with previous ipsilateral knee ligament surgery.

• Patients with orthopaedic and medical co-morbidities that would thwart postoperative recovery such as extra-articular pathology with referred pain to the knee (spinal stenosis, neuropathy, ipsilateral hip disease), severe knee deformity.

• Untreated Osteoarthritis

• BMI > 40

• ASA class > III

• History of drug or alcohol abuse

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Device:
• Verasense
Verasense will collect balancing data on all patients in this trial.

Locations

Country	Name	City	State
United States	Good Samarian Hospital	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
TriHealth Inc.	Orthosensor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction	Overall Patient Satisfaction will be reported through various surveys.	Surgery to 12 months post-operative