Knee Arthropathy Clinical Trial
Official title:
Effect of Nickel Sensitivity on Patient Reported Outcomes After Total Knee Arthroplasty
The purpose of this study is to compare clinical outcomes of patients with self reported nickel sensitivity undergoing primary total knee arthroplasty (TKA) with conventional, standard-of-care vs nickel-free implants. The hypothesis is that patients with a self-reported nickel sensitivity will have similar patient reported outcome scores compared to those patients without reported nickel sensitivity. Therefor the anticipation is for there to be no differences in other clinical outcome measures or functional outcome scores between the two cohorts.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | November 1, 2030 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients undergoing primary TKA for the diagnosis of osteoarthritis or inflammatory arthritis with self-reported nickel allergy. Patients are routinely asked about nickel sensitivity as a part of the standard pre operative questionnaire already in place. Exclusion Criteria: - Patients less than 18 years of age - Patients undergoing revision TKA - Non english speaking patients - Patient who have medical comorbidities that prevent elective TKA |
Country | Name | City | State |
---|---|---|---|
United States | Rush University medical Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Rush University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knee Society Score (KSS) | 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. | 3 weeks | |
Primary | Knee Society Score (KSS) | 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. | 6 weeks | |
Primary | Knee Society Score (KSS) | 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. | 1 year | |
Primary | Knee Society Score (KSS) | 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. | 2 years | |
Primary | Knee Society Score (KSS) | 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. | 5 years | |
Primary | Knee Society Score (KSS) | 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. | 10 years | |
Secondary | Complications | Any 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. | 90 days | |
Secondary | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) | Postoperative Knee Injury and Osteoarthritis Outcome Scores (KOOS JR) will also be recorded. This score is 0-100 with 100 being a perfectly functioning knee. | 3 weeks | |
Secondary | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) | Postoperative Knee Injury and Osteoarthritis Outcome Scores (KOOS JR) will also be recorded. This score is 0-100 with 100 being a perfectly functioning knee. | 6 weeks | |
Secondary | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) | Postoperative Knee Injury and Osteoarthritis Outcome Scores (KOOS JR) will also be recorded. This score is 0-100 with 100 being a perfectly functioning knee. | 1 year | |
Secondary | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) | Postoperative Knee Injury and Osteoarthritis Outcome Scores (KOOS JR) will also be recorded. This score is 0-100 with 100 being a perfectly functioning knee. | 2 years | |
Secondary | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) | Postoperative Knee Injury and Osteoarthritis Outcome Scores (KOOS JR) will also be recorded. This score is 0-100 with 100 being a perfectly functioning knee. | 5 years | |
Secondary | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) | Postoperative Knee Injury and Osteoarthritis Outcome Scores (KOOS JR) will also be recorded. This score is 0-100 with 100 being a perfectly functioning knee. | 10 years | |
Secondary | Radiographic assessment for proper component alignment and any signs of loosening | In addition, routine radiographs (AP and lateral knee radiographs) will be obtained at follow-up visits and assessed for component alignment and signs of loosening. | 3 weeks | |
Secondary | Radiographic assessment for proper component alignment and any signs of loosening | In addition, routine radiographs (AP and lateral knee radiographs) will be obtained at follow-up visits and assessed for component alignment and signs of loosening. | 6 weeks | |
Secondary | Radiographic assessment for proper component alignment and any signs of loosening | In addition, routine radiographs (AP and lateral knee radiographs) will be obtained at follow-up visits and assessed for component alignment and signs of loosening. | 1 year | |
Secondary | Radiographic assessment for proper component alignment and any signs of loosening | In addition, routine radiographs (AP and lateral knee radiographs) will be obtained at follow-up visits and assessed for component alignment and signs of loosening. | 2 years | |
Secondary | Radiographic assessment for proper component alignment and any signs of loosening | In addition, routine radiographs (AP and lateral knee radiographs) will be obtained at follow-up visits and assessed for component alignment and signs of loosening. | 5 years | |
Secondary | Radiographic assessment for proper component alignment and any signs of loosening | In addition, routine radiographs (AP and lateral knee radiographs) will be obtained at follow-up visits and assessed for component alignment and signs of loosening. | 10 years |
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