Making Sense Out of Total Knee Sensor Assisted Technology: A Randomized Control Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/9/2017 |
| Start Date: | November 2015 |
| End Date: | December 2019 |
| Contact: | Alexandra N Sympson, BA |
| Email: | alexandra_sympson@trihealth.com |
| Phone: | 513-862-1904 |
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
