Osteoarthritis
Conditions
Keywords
knee implant, knee replacement, total knee replacement
Brief summary
Patients will be consecutively enrolled by implant. Implant groups will be those who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system. The patient will conduct functional testing and answer questionnaires. The results will compare the ConforMIS iTotal with an Off the Shelf Knee replacement.
Detailed description
To compare functional and patient reported outcome data for a consecutively enrolled group of subjects who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.The person conducting the functional testing will be blinded to the device implanted. Sites will perform the off-the-shelf total knees conventional instrumentation.
Interventions
DEVICEOff the Shelf Total Knee Replacement
A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker
DEVICEConforMIS iTotal Knee Replacement
A knee replacement performed with patient specific implant and surgical jigs.
Sponsors
Restor3D
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Masking description
Site staff that is performing functional testing on subject is blinded to what implant the patient has.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: * Clinical condition included in the approved Indications For Use for the iTotal CR * Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment * Willingness to participate in the clinical study, to give informed consent and to attend all follow-up visits * \> 18 years of age Exclusion: * Subject will require a simultaneous bilateral procedure * Other lower extremity surgery within 1 year * Severe (\> 15º) fixed valgus or varus deformity * Severe (\> 15º) extension deficit * Severe instability due to advanced loss of osteochondral structure * Loss of bone or musculature, osteoporosis, neuromuscular or vascular compromise in the area of the joint to be operated on to an extent that the procedure is unjustified * Insufficient bone stock on the femoral or tibial surfaces * Contralateral knee replacement surgery within the past 6 months * BMI \> 40 * Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years * Poorly controlled diabetes (defined as HbA1c \>7 or surgeon discretion) * Immunocompromised * Other physical disability affecting the hips, spine, or contralateral knee that limits function * Disabling chronic pain with narcotic dependence * Compromised PCL or collateral ligament * Prior history of failed implant surgery of the joint to be treated, including Unicompartmental Knee Arthroplasty (UKA), or Bicompartmental Knee Arthroplasty (BKA) * Prior history of failed high tibial osteotomy (HTO) * Participation in another clinical study which would confound results * Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure | 1 year | Comparing the functional testing differences between iTotal and off the shelf. Total Functional Activities Score - a subscale within the Knee Society Score (KSS) with its individual subscale score. The Total Functional Activities Score subscale interprets the functional knee health of each patient via a series of tests such as walking/standing (30 points), standard activities (30 points), advanced activities (25 points), and sports/recreational activities (15 points). Deductions to score are made for factors that limit a patient's mobility, such as needing to use an ambulatory device. The subscale scoring system ranges from 0-100, with higher scores indicating better knee function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure | 1 year | Measuring and comparing the differences between iTotal and off the shelf knees with patient reported outcomes. Patient Satisfaction, a subscale within the Knee Society Score (KSS), was utilized to capture this metric. The Patient Satisfaction subscale combines scores given for certain responses (very satisfied, satisfied, neutral, somewhat dissatisfied, very dissatisfied) across 5 questions. These questions are designed to determine the level of satisfaction a patient has with their implant across both everyday and active activities. This score ranges from 0-40, with higher scores indicating higher levels of patient satisfaction. |
| Incidents of Major Procedure-related and Device Related Complications (Including Revision Rates) | 1 year | All complications were stratified according to clinicaltrials.gov reporting standards and each site labeled each complication as either device-related, non-device-related, procedure-related, and non-procedure-related. |
Countries
United States
Participant flow
Recruitment details
While Biomet Total Knee Replacement and Smith and Nephew Total Knee Replacement Arms/Groups were listed as possible study groups, no included patients utilized these implant systems. This included patients who failed to meet screening criteria, failed to reach the protocol's required follow-up duration, etc. These arms/groups were only established before the study to represent the possible study groups based on available implant systems on the market.
Participants by arm
| Arm | Count |
|---|---|
| ConforMIS iTotal Knee Replacement iTotal patient-specific knee replacement system
ConforMIS iTotal Knee Replacement: A knee replacement performed with patient specific implant and surgical jigs. | 81 |
| DePuy Total Knee Replacement Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker | 28 |
| Zimmer Total Knee Replacement Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker | 19 |
| Biomet Total Knee Replacement Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker | 0 |
| Smith & Nephew Total Knee Replacement Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker | 0 |
| Stryker Total Knee Replacement Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker | 19 |
| Total | 147 |
Baseline characteristics
| Characteristic | Zimmer Total Knee Replacement | Biomet Total Knee Replacement | DePuy Total Knee Replacement | Smith & Nephew Total Knee Replacement | ConforMIS iTotal Knee Replacement | Stryker Total Knee Replacement | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 0 Participants | 18 Participants | 0 Participants | 39 Participants | 14 Participants | 80 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 0 Participants | 10 Participants | 0 Participants | 42 Participants | 5 Participants | 67 Participants |
| Age, Continuous | 63 years STANDARD_DEVIATION 8.524 | — | 67.321 years STANDARD_DEVIATION 6.842 | — | 65.728 years STANDARD_DEVIATION 7.482 | 68.105 years STANDARD_DEVIATION 6.59 | 65.986 years STANDARD_DEVIATION 7.468 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | — | 0 Participants | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | — | 2 Participants | — | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | — | 6 Participants | — | 12 Participants | 2 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | — | 0 Participants | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | — | 0 Participants | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | — | 4 Participants | — | 1 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) White | 19 Participants | — | 16 Participants | — | 68 Participants | 17 Participants | 120 Participants |
| Region of Enrollment Germany | 0 participants | — | 1 participants | — | 8 participants | 9 participants | 19 participants |
| Region of Enrollment United States | 19 participants | — | 27 participants | — | 73 participants | 10 participants | 128 participants |
| Sex: Female, Male Female | 13 Participants | — | 19 Participants | — | 45 Participants | 12 Participants | 89 Participants |
| Sex: Female, Male Male | 6 Participants | — | 9 Participants | — | 36 Participants | 7 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 28 | 0 / 19 | 0 / 0 | 0 / 0 | 0 / 19 |
| other Total, other adverse events | 26 / 81 | 7 / 28 | 1 / 19 | 0 / 0 | 0 / 0 | 7 / 19 |
| serious Total, serious adverse events | 13 / 81 | 6 / 28 | 2 / 19 | 0 / 0 | 0 / 0 | 0 / 19 |
Outcome results
Primary
Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure
Comparing the functional testing differences between iTotal and off the shelf. Total Functional Activities Score - a subscale within the Knee Society Score (KSS) with its individual subscale score. The Total Functional Activities Score subscale interprets the functional knee health of each patient via a series of tests such as walking/standing (30 points), standard activities (30 points), advanced activities (25 points), and sports/recreational activities (15 points). Deductions to score are made for factors that limit a patient's mobility, such as needing to use an ambulatory device. The subscale scoring system ranges from 0-100, with higher scores indicating better knee function.
Time frame: 1 year
Population: Patients that met inclusion criteria and had KSS Total Functional Activities Score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ConforMIS iTotal Knee Replacement | Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure | 1 Year Score | 77.16 Score on a subscale | Standard Deviation 16.47 |
| ConforMIS iTotal Knee Replacement | Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure | Change in Score | 34.82 Score on a subscale | Standard Deviation 21.73 |
| ConforMIS iTotal Knee Replacement | Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure | Baseline Score | 42.34 Score on a subscale | Standard Deviation 16.31 |
| DePuy Total Knee Replacement | Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure | Baseline Score | 40.38 Score on a subscale | Standard Deviation 13.07 |
| DePuy Total Knee Replacement | Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure | 1 Year Score | 73.65 Score on a subscale | Standard Deviation 16.99 |
| DePuy Total Knee Replacement | Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure | Change in Score | 33.27 Score on a subscale | Standard Deviation 18.28 |
| Zimmer Total Knee Replacement | Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure | Change in Score | 45.39 Score on a subscale | Standard Deviation 13.18 |
| Zimmer Total Knee Replacement | Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure | 1 Year Score | 88.94 Score on a subscale | Standard Deviation 6.2 |
| Zimmer Total Knee Replacement | Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure | Baseline Score | 43.56 Score on a subscale | Standard Deviation 12.38 |
| Stryker Total Knee Replacement | Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure | 1 Year Score | 71.20 Score on a subscale | Standard Deviation 23.63 |
| Stryker Total Knee Replacement | Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure | Change in Score | 32.33 Score on a subscale | Standard Deviation 19.21 |
| Stryker Total Knee Replacement | Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure | Baseline Score | 38.87 Score on a subscale | Standard Deviation 13.53 |
Secondary
Incidents of Major Procedure-related and Device Related Complications (Including Revision Rates)
All complications were stratified according to clinicaltrials.gov reporting standards and each site labeled each complication as either device-related, non-device-related, procedure-related, and non-procedure-related.
Time frame: 1 year
Population: No included patients utilized the Biomet or Smith \& Nephew total knee replacement systems.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ConforMIS iTotal Knee Replacement | Incidents of Major Procedure-related and Device Related Complications (Including Revision Rates) | Device Related Complications (including revision) | 1 Patients with Events |
| ConforMIS iTotal Knee Replacement | Incidents of Major Procedure-related and Device Related Complications (Including Revision Rates) | Major Procedure Related Complications | 12 Patients with Events |
| DePuy Total Knee Replacement | Incidents of Major Procedure-related and Device Related Complications (Including Revision Rates) | Major Procedure Related Complications | 5 Patients with Events |
| DePuy Total Knee Replacement | Incidents of Major Procedure-related and Device Related Complications (Including Revision Rates) | Device Related Complications (including revision) | 0 Patients with Events |
| Zimmer Total Knee Replacement | Incidents of Major Procedure-related and Device Related Complications (Including Revision Rates) | Major Procedure Related Complications | 1 Patients with Events |
| Zimmer Total Knee Replacement | Incidents of Major Procedure-related and Device Related Complications (Including Revision Rates) | Device Related Complications (including revision) | 0 Patients with Events |
| Stryker Total Knee Replacement | Incidents of Major Procedure-related and Device Related Complications (Including Revision Rates) | Device Related Complications (including revision) | 0 Patients with Events |
| Stryker Total Knee Replacement | Incidents of Major Procedure-related and Device Related Complications (Including Revision Rates) | Major Procedure Related Complications | 3 Patients with Events |
Secondary
Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure
Measuring and comparing the differences between iTotal and off the shelf knees with patient reported outcomes. Patient Satisfaction, a subscale within the Knee Society Score (KSS), was utilized to capture this metric. The Patient Satisfaction subscale combines scores given for certain responses (very satisfied, satisfied, neutral, somewhat dissatisfied, very dissatisfied) across 5 questions. These questions are designed to determine the level of satisfaction a patient has with their implant across both everyday and active activities. This score ranges from 0-40, with higher scores indicating higher levels of patient satisfaction.
Time frame: 1 year
Population: Patients that met inclusion criteria and had patient satisfaction data were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ConforMIS iTotal Knee Replacement | Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure | 1 Year Score | 33.78 score on a scale | Standard Deviation 8.28 |
| ConforMIS iTotal Knee Replacement | Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure | Change in Score | 21.29 score on a scale | Standard Deviation 10.76 |
| ConforMIS iTotal Knee Replacement | Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure | Baseline Score | 12.49 score on a scale | Standard Deviation 7.09 |
| DePuy Total Knee Replacement | Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure | Change in Score | 18.38 score on a scale | Standard Deviation 9.63 |
| DePuy Total Knee Replacement | Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure | Baseline Score | 13.62 score on a scale | Standard Deviation 6.5 |
| DePuy Total Knee Replacement | Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure | 1 Year Score | 32.00 score on a scale | Standard Deviation 7.8 |
| Zimmer Total Knee Replacement | Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure | Change in Score | 21.78 score on a scale | Standard Deviation 8.08 |
| Zimmer Total Knee Replacement | Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure | Baseline Score | 15.67 score on a scale | Standard Deviation 7.65 |
| Zimmer Total Knee Replacement | Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure | 1 Year Score | 37.44 score on a scale | Standard Deviation 3.81 |
| Stryker Total Knee Replacement | Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure | 1 Year Score | 32.93 score on a scale | Standard Deviation 6.84 |
| Stryker Total Knee Replacement | Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure | Change in Score | 17.73 score on a scale | Standard Deviation 8.71 |
| Stryker Total Knee Replacement | Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure | Baseline Score | 15.50 score on a scale | Standard Deviation 6.67 |