Trial Outcomes & Findings for Nickel Sensitivity (NCT NCT04058743)
NCT ID: NCT04058743
Last Updated: 2026-05-01
Results Overview
Change from pre operative to post operative Knee Society Scores at various time intervals. KSS is scored 0-100 with 100 being a perfectly functioning knee and is used as a gauge of success for a knee replacement.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
3 weeks
Results posted on
2026-05-01
Participant Flow
Participant milestones
| Measure |
TKA With Standard Cobalt Chromium Components
Patients randomized to this group will receive the standard cobalt chromium components in their total knee arthroplasty
TKA with standard cobalt chromium components: Patients will be randomized to receive either the standard cobalt chromium components or nickel free components
|
TKA With Nickel Free Components
Patients randomized to this group will receive nickel free components in their total knee arthroplasty
TKA with nickel free components: Patients will be randomized to receive either the standard cobalt chromium components or nickel free components
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
TKA With Standard Cobalt Chromium Components
Patients randomized to this group will receive the standard cobalt chromium components in their total knee arthroplasty
TKA with standard cobalt chromium components: Patients will be randomized to receive either the standard cobalt chromium components or nickel free components
|
TKA With Nickel Free Components
Patients randomized to this group will receive nickel free components in their total knee arthroplasty
TKA with nickel free components: Patients will be randomized to receive either the standard cobalt chromium components or nickel free components
|
|---|---|---|
|
Overall Study
Closed study early due to poor enrollment
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TKA With Nickel Free Components
n=3 Participants
Patients randomized to this group will receive nickel free components in their total knee arthroplasty
TKA with nickel free components: Patients will be randomized to receive either the standard cobalt chromium components or nickel free components
|
Total
n=8 Participants
Total of all reporting groups
|
TKA With Standard Cobalt Chromium Components
n=5 Participants
Patients randomized to this group will receive the standard cobalt chromium components in their total knee arthroplasty
TKA with standard cobalt chromium components: Patients will be randomized to receive either the standard cobalt chromium components or nickel free components
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=3 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=3 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
n=3 Participants
|
58.3 years
n=8 Participants
|
60.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=3 Participants
|
8 Participants
n=8 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
—
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
8 participants
n=8 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeksChange from pre operative to post operative Knee Society Scores at various time intervals. KSS is scored 0-100 with 100 being a perfectly functioning knee and is used as a gauge of success for a knee replacement.
Outcome measures
| Measure |
TKA With Nickel Free Components
n=3 Participants
Patients randomized to this group will receive nickel free components in their total knee arthroplasty
TKA with nickel free components: Patients will be randomized to receive either the standard cobalt chromium components or nickel free components
|
TKA With Standard Cobalt Chromium Components
n=5 Participants
Patients randomized to this group will receive the standard cobalt chromium components in their total knee arthroplasty
TKA with standard cobalt chromium components: Patients will be randomized to receive either the standard cobalt chromium components or nickel free components
|
|---|---|---|
|
Knee Society Score (KSS)
|
69.5 score on a scale
Interval 35.0 to 99.0
|
56 score on a scale
Interval 52.0 to 61.0
|
SECONDARY outcome
Timeframe: 90 daysAny peri- or postoperative complications will be recorded including DVT/PE, return to the OR within 90 days, readmission within 90 days, superficial infection, deep infection, dermatitis, periprosthetic fracture, cerebrovascular accident/transient ischemic attack.
Outcome measures
| Measure |
TKA With Nickel Free Components
n=3 Participants
Patients randomized to this group will receive nickel free components in their total knee arthroplasty
TKA with nickel free components: Patients will be randomized to receive either the standard cobalt chromium components or nickel free components
|
TKA With Standard Cobalt Chromium Components
n=5 Participants
Patients randomized to this group will receive the standard cobalt chromium components in their total knee arthroplasty
TKA with standard cobalt chromium components: Patients will be randomized to receive either the standard cobalt chromium components or nickel free components
|
|---|---|---|
|
Number of Participants With Complications
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 weeksPostoperative Knee Injury and Osteoarthritis Outcome Scores (KOOS JR) will also be recorded. This score is 0-100 with 100 being a perfectly functioning knee.
Outcome measures
| Measure |
TKA With Nickel Free Components
n=3 Participants
Patients randomized to this group will receive nickel free components in their total knee arthroplasty
TKA with nickel free components: Patients will be randomized to receive either the standard cobalt chromium components or nickel free components
|
TKA With Standard Cobalt Chromium Components
n=5 Participants
Patients randomized to this group will receive the standard cobalt chromium components in their total knee arthroplasty
TKA with standard cobalt chromium components: Patients will be randomized to receive either the standard cobalt chromium components or nickel free components
|
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)
|
64.1 score on a scale
Interval 50.0 to 76.3
|
56.9 score on a scale
Interval 47.5 to 61.6
|
SECONDARY outcome
Timeframe: 6 weeksPostoperative Knee Injury and Osteoarthritis Outcome Scores (KOOS JR) will also be recorded. This score is 0-100 with 100 being a perfectly functioning knee.
Outcome measures
| Measure |
TKA With Nickel Free Components
n=3 Participants
Patients randomized to this group will receive nickel free components in their total knee arthroplasty
TKA with nickel free components: Patients will be randomized to receive either the standard cobalt chromium components or nickel free components
|
TKA With Standard Cobalt Chromium Components
n=5 Participants
Patients randomized to this group will receive the standard cobalt chromium components in their total knee arthroplasty
TKA with standard cobalt chromium components: Patients will be randomized to receive either the standard cobalt chromium components or nickel free components
|
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)
|
61.1 score on a scale
Interval 36.9 to 70.7
|
59.9 score on a scale
Interval 58.8 to 61.6
|
SECONDARY outcome
Timeframe: 3 weeks after surgeryRadiographic review was done at 3 weeks after surgery to assess for component alignment and review for signs of loosening.
Outcome measures
| Measure |
TKA With Nickel Free Components
n=3 Participants
Patients randomized to this group will receive nickel free components in their total knee arthroplasty
TKA with nickel free components: Patients will be randomized to receive either the standard cobalt chromium components or nickel free components
|
TKA With Standard Cobalt Chromium Components
n=5 Participants
Patients randomized to this group will receive the standard cobalt chromium components in their total knee arthroplasty
TKA with standard cobalt chromium components: Patients will be randomized to receive either the standard cobalt chromium components or nickel free components
|
|---|---|---|
|
Number of Participants With Proper Component Alignment and *Without* Any Signs of Loosening
Patients with signs of loosening
|
0 Participants
|
0 Participants
|
|
Number of Participants With Proper Component Alignment and *Without* Any Signs of Loosening
patients without signs of loosening
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 weeks after surgeryx-rays done at 6 weeks after surgery were evaluated (standing AP, skiers and lateral views)
Outcome measures
| Measure |
TKA With Nickel Free Components
n=3 Participants
Patients randomized to this group will receive nickel free components in their total knee arthroplasty
TKA with nickel free components: Patients will be randomized to receive either the standard cobalt chromium components or nickel free components
|
TKA With Standard Cobalt Chromium Components
n=5 Participants
Patients randomized to this group will receive the standard cobalt chromium components in their total knee arthroplasty
TKA with standard cobalt chromium components: Patients will be randomized to receive either the standard cobalt chromium components or nickel free components
|
|---|---|---|
|
Number of Participants With Proper Component Alignment and *Without* Any Signs of Loosening
patients with signs of loosening
|
0 Participants
|
0 Participants
|
|
Number of Participants With Proper Component Alignment and *Without* Any Signs of Loosening
patients without signs of loosening
|
3 Participants
|
5 Participants
|
Adverse Events
TKA With Standard Cobalt Chromium Components
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TKA With Nickel Free Components
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place