Trial Outcomes & Findings for iAssist vs. Conventional Instrumentation in Total Knee Arthroplasty (NCT NCT03111407)
NCT ID: NCT03111407
Last Updated: 2021-04-13
Results Overview
Assess the differences in component alignment, measured by the mean of radiographs, between iASSIST™ and conventional instrumentation in primary total knee arthroplasty (TKA) procedures.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
1 year
Results posted on
2021-04-13
Participant Flow
75 patients were intended to be enrolled according to the protocol but only 72 were finally enrolled.
Participant milestones
| Measure |
iAssist Group
45 iASSIST cases have been enrolled in 3 sites between April 2014 and August 2017.
|
Conventional Instrumentation Group
27 conventional instrumentation cases have been enrolled in 3 sites between April 2014 and August 2017.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
27
|
|
Overall Study
COMPLETED
|
44
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
iAssist Group
n=45 Participants
45 iASSIST cases have been enrolled in 3 sites between April 2014 and August 2017.
|
Conventional Instrumentation Group
n=27 Participants
27 conventional cases have been enrolled in 3 sites between April 2014 and August 2017.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 7.9 • n=45 Participants
|
70.3 years
STANDARD_DEVIATION 7.4 • n=27 Participants
|
68.4 years
STANDARD_DEVIATION 7.8 • n=72 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=45 Participants
|
17 Participants
n=27 Participants
|
47 Participants
n=72 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=45 Participants
|
10 Participants
n=27 Participants
|
25 Participants
n=72 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Weight kg
|
81.4 kg
STANDARD_DEVIATION 17.2 • n=45 Participants
|
84.3 kg
STANDARD_DEVIATION 13.0 • n=27 Participants
|
82.5 kg
STANDARD_DEVIATION 15.7 • n=72 Participants
|
|
Body Mass Index (BMI) kg/m^2
|
30.4 kg/m^2
STANDARD_DEVIATION 5.5 • n=45 Participants
|
30.7 kg/m^2
STANDARD_DEVIATION 4.6 • n=27 Participants
|
30.5 kg/m^2
STANDARD_DEVIATION 5.1 • n=72 Participants
|
|
Height cm
|
163.5 cm
STANDARD_DEVIATION 10.6 • n=45 Participants
|
166.0 cm
STANDARD_DEVIATION 9.6 • n=27 Participants
|
164.5 cm
STANDARD_DEVIATION 10.3 • n=72 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Available data of enrolled patients were used for analysis.
Assess the differences in component alignment, measured by the mean of radiographs, between iASSIST™ and conventional instrumentation in primary total knee arthroplasty (TKA) procedures.
Outcome measures
| Measure |
iAssist Group
n=44 Participants
45 iASSIST cases have been enrolled in 3 sites between April 2014 and August 2017.
|
Conventional Instrumentation Group
n=26 Participants
27 conventional cases have been enrolled in 3 sites between April 2014 and August 2017.
|
|---|---|---|
|
Component Alignment
|
179 degree
Standard Deviation 2.9
|
178 degree
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Available data of enrolled patients were used for analysis.
Assess the differences in Knee Society Score between iASSIST™ and conventional instrumentation in primary TKA procedures. Higher (and better) score value: 100, lower value: 0. Score 80-100 = Excellent Score 70-79 = Good Score 60-69 = Fair Score below 60 = Poor
Outcome measures
| Measure |
iAssist Group
n=44 Participants
45 iASSIST cases have been enrolled in 3 sites between April 2014 and August 2017.
|
Conventional Instrumentation Group
n=26 Participants
27 conventional cases have been enrolled in 3 sites between April 2014 and August 2017.
|
|---|---|---|
|
Knee Society Score Assessment
|
74.7 score on a scale
Standard Deviation 12.5
|
72.4 score on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Available data of enrolled patients were used for analysis.
Knee Society Score function asses 12 months postoperatively between iASSIST™ and conventional instrumentation in primary TKA procedures. Higher (and better) score value: 100, lower value: 0. Score 80-100 = Excellent Score 70-79 = Good Score 60-69 = Fair Score below 60 = Poor
Outcome measures
| Measure |
iAssist Group
n=44 Participants
45 iASSIST cases have been enrolled in 3 sites between April 2014 and August 2017.
|
Conventional Instrumentation Group
n=27 Participants
27 conventional cases have been enrolled in 3 sites between April 2014 and August 2017.
|
|---|---|---|
|
Knee Society Score Function
|
80.5 score on a scale
Standard Deviation 13.8
|
78.5 score on a scale
Standard Deviation 19.1
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Available data of enrolled patients were used for analysis.
Assess the differences in EQ-5D between iASSIST™ and conventional instrumentation in primary TKA procedures at 12 months postoperatively. Comparison of the derived EQ-5D scale and health state between the 2 groups. The EQ-5D questionnaire includes five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. EQ-5D values range from -0.2 to 1 where the negative values correspond to bad health states (states worse than death), and 1.0 corresponds to perfect health.
Outcome measures
| Measure |
iAssist Group
n=29 Participants
45 iASSIST cases have been enrolled in 3 sites between April 2014 and August 2017.
|
Conventional Instrumentation Group
n=20 Participants
27 conventional cases have been enrolled in 3 sites between April 2014 and August 2017.
|
|---|---|---|
|
EQ-5D Questionnaire
|
0.8 score on a scale
Standard Deviation 0.2
|
0.8 score on a scale
Standard Deviation 0.3
|
Adverse Events
iAssist Group
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Conventional Instrumentation Group
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
iAssist Group
n=45 participants at risk
45 iASSIST cases have been enrolled in 3 sites between April 2014 and August 2017.
|
Conventional Instrumentation Group
n=27 participants at risk
27 conventional cases have been enrolled in 3 sites between April 2014 and August 2017.
|
|---|---|---|
|
Surgical and medical procedures
Poor alignment in tibia component
|
2.2%
1/45 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
0.00%
0/27 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
|
Infections and infestations
Sepsis in bronchial asthma, infection exacerbation
|
2.2%
1/45 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
0.00%
0/27 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
|
Surgical and medical procedures
Implant failure
|
0.00%
0/45 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
3.7%
1/27 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/45 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
3.7%
1/27 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
|
General disorders
Lump in the neck: metastasis,as well as in the lungs
|
0.00%
0/45 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
3.7%
1/27 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
|
Surgical and medical procedures
Patella transverse fracture+dislocation of the prosthesis+tibia shaft fracture+infe
|
0.00%
0/45 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
3.7%
1/27 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
Other adverse events
| Measure |
iAssist Group
n=45 participants at risk
45 iASSIST cases have been enrolled in 3 sites between April 2014 and August 2017.
|
Conventional Instrumentation Group
n=27 participants at risk
27 conventional cases have been enrolled in 3 sites between April 2014 and August 2017.
|
|---|---|---|
|
General disorders
Allergic reaction after eating nuts
|
2.2%
1/45 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
0.00%
0/27 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
|
General disorders
Allergic reaction unclear cause (itching, dyspnea, rash)
|
2.2%
1/45 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
0.00%
0/27 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
|
Surgical and medical procedures
Radius fracture
|
2.2%
1/45 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
0.00%
0/27 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
|
General disorders
Flexion Contracture
|
2.2%
1/45 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
3.7%
1/27 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
|
General disorders
Allergic reaction (Dafalgan)
|
2.2%
1/45 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
0.00%
0/27 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
|
Surgical and medical procedures
Foot fracture
|
2.2%
1/45 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
0.00%
0/27 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
|
Surgical and medical procedures
Delayed Wound Healing
|
2.2%
1/45 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
0.00%
0/27 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
|
Social circumstances
Fall from the bed
|
2.2%
1/45 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
0.00%
0/27 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
|
Vascular disorders
Pain in the calf (deep vein thrombosis)
|
0.00%
0/45 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
3.7%
1/27 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
|
Social circumstances
patient felt on the floor, he wanted to stand up alone
|
0.00%
0/45 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
3.7%
1/27 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
|
Surgical and medical procedures
Patient still had a joint effusion 6 months after surgery
|
0.00%
0/45 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
3.7%
1/27 • The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3 months ±2 weeks and 12 months ±1 month postoperative).
|
Additional Information
Emilie Rohmer, Clinical Operations Manager
Zimmer Biomet
Phone: +41 58 85 48210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place