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The sponsor decided to close the study early due to low patient enrollment and the sponsor no longer pursuing stem cell therapy treatment.
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This is a prospective, multi-location safety and effectiveness study, and data registry of autologous adult ADRCs generated by the Transpose® RT System in subjects with OA in the shoulder, wrist, knee, hip, or ankle.
Subjects who have signed informed consent and Health Insurance Portability and Accountability Act (HIPPA) authorization, and are determined to meet all inclusion criteria and no exclusion criteria will be enrolled in this study and receive the ADRC treatment.
The subject will have an injection procedure (ADRC treatment) For this study, a licensed physician trained in liposuction must perform the syringe liposuction procedure. The licensed physician who performs the lipoplasty may be the Investigator or a non-Investigator physician (e.g., a plastic surgeon) who is trained on the study protocol.
All subjects will undergo a minor syringe liposuction procedure to acquire approximately 100 mL of lipoaspirate for preparation of ADRC using the Transpose® RT System. The removed tissue is processed to extract a cell suspension (the cell product). Once the cell product has been obtained, tested, and found to conform to release criteria, the subject will be treated with the ADRCs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hip Osteoarthritis | Subjects will receive autologous adipose-derived regenerative stem cells into their affected hip joint. |
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| Knee Osteoarthritis | Subjects will receive autologous adipose-derived regenerative stem cells into their affected knee joint. |
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| Ankle Osteoarthritis | Subjects will receive autologous adipose-derived regenerative stem cells into their affected ankle joint. |
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| Shoulder Osteoarthritis | Subjects will receive autologous adipose-derived regenerative stem cells into their affected shoulder joint. |
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| Wrist Osteoarthritis | Subjects will receive autologous adipose-derived regenerative stem cells into their affected wrist joint. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adipose-derived regenerative cells | Device | Adipose-derived regenerative cells will be obtained from a small-volume lipoaspirate procedure. The lipoaspirate will then be enzymatically digested to produce a stromal vascular fraction (SVF) that will be injected into the targeted joint. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as indicated by incidence (%) of unanticipated AEs. All AEs and SAEs will be graded on severity by the Investigator using the National Institutes of Health Common Terminology Criteria for Adverse Events (NIH CTCAE). | A one-sided binomial test will be used with a significance level of 0.05 to test whether safety was significantly lower than 20%. Each cohort will be analyzed independently. | Up to 2 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the knee using PROMIS 10 Global health | The PROMIS® is a set of participant-centered measures that evaluates and monitors the physical, mental, and social health in adults. Although unknown in osteoarthritis, the PROMIS® 10 Global Heath Survey was developed by the National Institute of Health and validated across a variety of chronic conditions. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable". | Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the knee using SF-12v2 | The SF-12v2 is a generic health outcome measurement widely used in chronic illness and chronic pain conditions. The SF-12v2 is a shorter tool that requires less patient and provider effort. Validity and feasibility have been reviewed with demonstration for significance in non-cancer pain patients.Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. SF-12v2 patient-reported questionnaire is utilizes a 5-point scale ranging from "Excellent"/"All of the time" to "None of the time"/"Poor" for both physical and mental questions as well as a 3-point score ranging from "Yes, limited a lot" to "No, not limited at all" for two physical questions. |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objective is to create a data registry for future research on ADRC use for OA | The registry will only contain treated individuals. Future analyses will analyze all subjects, subsets of subjects based on area of treatment, or potentially match treated subjects to similar control subjects for comparison of outcomes. | Through study completion, up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| A small volume of each subject's ADRC will be processed and stored for future research. | A small volume of each subject's ADRC will be processed and stored for future research. | Through study completion, up to 3 years |
All Cohorts:
To be eligible to participate in this study, a subject must meet all the following criteria.
Inclusion Criteria-ALL Cohorts:
Ankle Cohort:
Hip Cohort:
1. Hip OA diagnosed on x-ray and/or Magnetic Resonance Imaging (MRI) (Tӧnnis grade 1, 2, or 3)
Knee Cohort:
Shoulder Cohort:
Grades 1, 2 or 3 OA in the index glenohumeral joint based on the Samilson-Prieto classification system as confirmed by X-ray (axillary view and true anterior-posterior view)
Subjects who have failed standard non-surgical management of their shoulder arthritis who would benefit from a shoulder arthroplasty. Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for 6 months. Medical management will be defined as:
Wrist Cohort:
1. Clinical symptoms consistent with wrist OA
Exclusion Criteria- ALL Cohorts:
Ankle Cohort:
Hip Cohort:
Knee Cohort:
Shoulder Cohort:
Wrist Cohort:
1. Subjects who have a documented diagnosis of active carpal tunnel syndrome
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The focus of this study is to investigate the therapeutic benefit of autologous ADRCs in patients with OA in various joints. The ENDURE study allows subjects at Sanford Health and in the United States access to adipose-derived regenerative cells while reviewing safety for subjects with knee, shoulder, hip, ankle and wrist OA, using a more pragmatic and standard clinical approach.
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| Name | Affiliation | Role |
|---|---|---|
| David A. Pearce, PhD | Sanford Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanford Orthopedics and Sports Medicine | Sioux Falls | South Dakota | 57104 | United States |
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After completion of the product release criteria testing, a small amount of the sample will be processed and stored for future research. These retained samples will be used for future research. Future research results will not be returned to the study participants or investigators.
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| Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the knee using the Visual Analog Pain Scale (VAS-Pain) | A VAS instrument measures a characteristic that spans a continuum, cannot be precisely or optimally measured by or would lack sensitivity in distinguishing subtle changes on an ordinal scale. Pain intensity is a characteristic that is commonly measured in this manner. A 100-mm VAS will be administered to assess the subject's experience of joint pain intensity. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The visual analog scale (VAS) patient-reported questionnaire is a subjective measure for acute and chronic pain utilizing a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain". | Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the knee using the Knee Osteoarthritis Outcome Score (KOOS) | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a valid, reliable, and responsive outcome measure in total joint replacement (E. T.-L. Roos 2003). KOOS is a self-administered questionnaire that assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The KOOS's patient-reported questionnaire utilizes 5-point Likert scale, options scored from 0 (No problems) to 4 (Extreme problems). | Through study completion, up to 3 years |
| Efficacy outcomes include changes in the range of motion of the knee (ROM) measurements for the knee | Ranges include: 0-140 degrees flexion 0 degrees extension | Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the shoulder using PROMIS 10 Global health | The PROMIS® is a set of participant-centered measures that evaluates and monitors the physical, mental, and social health in adults. Although unknown in osteoarthritis, the PROMIS® 10 Global Heath Survey was developed by the National Institute of Health and validated across a variety of chronic conditions. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable". | Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the shoulder using SF-12v2 | The SF-12v2 is a generic health outcome measurement widely used in chronic illness and chronic pain conditions. The SF-12v2 is a shorter tool that requires less patient and provider effort. Validity and feasibility have been reviewed with demonstration for significance in non-cancer pain patients. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. SF-12v2 patient-reported questionnaire is utilizes a 5-point scale ranging from "Excellent"/"All of the time" to "None of the time"/"Poor" for both physical and mental questions as well as a 3-point score ranging from "Yes, limited a lot" to "No, not limited at all" for two physical questions. | Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the shoulder using the Visual Analog Pain Scale (VAS-Pain) | A VAS instrument measures a characteristic that spans a continuum, cannot be precisely or optimally measured by or would lack sensitivity in distinguishing subtle changes on an ordinal scale. Pain intensity is a characteristic that is commonly measured in this manner. A 100-mm VAS will be administered to assess the subject's experience of joint pain intensity. The visual analog scale (VAS) patient-reported questionnaire is a subjective measure for acute and chronic pain utilizing a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain". | Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the shoulder using American Surgeon and Elbow Surgeon (ASES) measure | The ASES is a 100-point scale that consists of questions related to pain and activities of daily living. It is comprised of patient self-evaluation section and a physician assessment section.The activities of daily living questionnaire are marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. The physician assessment section includes demographic information and assess range of motion, specific physical signs, strength and stability. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). The ASES is a 17-item patient-reported questionnaire utilizing a 10-point pain scale ranging from 0="No pain at all" to 10="Pain as bad as it can be" and a 4-point activities of daily living scale ranging from 0="Unable to do" to 3="Normal" | Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the shoulder using the Oxford Shoulder Score | The Oxford Shoulder Score (OSS) is validated patient-reported outcome providing researchers and clinicians with a quantitative measure of a patient's response after a surgical and non-surgical shoulder intervention. Developed by the Department of Public Heath in the United Kingdom, the OSS is a 12-item tool used to review patient's pain and function, and is widely utilized in clinical trials. The Oxford Shoulder Score (OSS) is a 12-item patient-reported questionnaire utilizing as a 5-point Likert scale ranging from "None"/No trouble at all" to "Unbearable"/"Impossible to do". | Through study completion, up to 3 years |
| Efficacy outcomes include changes in the range of motion of the shoulder (ROM) | Ranges include: 0-180 degrees forward flexion 0-150 degrees abduction 30 degrees adduction 70-90 degrees internal rotation 0-90 degrees external rotation | Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the wrist using PROMIS 10 Global health | The PROMIS® is a set of participant-centered measures that evaluates and monitors the physical, mental, and social health in adults. Although unknown in osteoarthritis, the PROMIS® 10 Global Heath Survey was developed by the National Institute of Health and validated across a variety of chronic conditions. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable". | Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the wrist using SF-12v2 | The SF-12v2 is a generic health outcome measurement widely used in chronic illness and chronic pain conditions. The SF-12v2 is a shorter tool that requires less patient and provider effort. Validity and feasibility have been reviewed with demonstration for significance in non-cancer pain patients. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. SF-12v2 patient-reported questionnaire is utilizes a 5-point scale ranging from "Excellent"/"All of the time" to "None of the time"/"Poor" for both physical and mental questions as well as a 3-point score ranging from "Yes, limited a lot" to "No, not limited at all" for two physical questions. | Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the wrist using the Pain Score Analog Scale (VAS-Pain) | A VAS instrument measures a characteristic that spans a continuum, cannot be precisely or optimally measured by or would lack sensitivity in distinguishing subtle changes on an ordinal scale. Pain intensity is a characteristic that is commonly measured in this manner. A 100-mm VAS will be administered to assess the subject's experience of joint pain intensity. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. | Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the wrist using the Quick-Dash | The subject will complete the QuickDASH by scoring each item of the questionnaire with scores between 1 (no difficulty at all) and 5 (unable to do), with higher scores indicating greater disability (Hudak 1996, Kennedy 2011). The QuickDASH questionnaire is considered complete when 10 of the total 11 items are answered. The QuickDASH is an 11 item patient-reported questionnaire utilizing as a 5-point Likert scale ranging from 1="No difficulty"/"None" to 5="Unable to perform"/"Extreme". | Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the wrist using PROMIS-Upper Extremity | The subject will complete the PROMIS self-report without help from anyone else. The respondents will be given the optimal time needed to capture the most relevant perspective and complete data (e.g., before/after clinician visit or in between visits). All results will be recorded and analyzed in accordance with standard practice. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort.PROMIS- Upper Extremity is a 7-item patient-reported questionnaire utilizing as 5-point scale ranging from 5="Without any difficulty" to 1="Unable to do". | Through study completion, up to 3 years |
| Efficacy outcomes include changes in the range of motion of the wrist (ROM) | Ranges include: 0-75 degrees flexion 0-70 degrees extension 50 degrees radioulnar deviation arc | Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the ankle using PROMIS 10 Global health | The PROMIS® is a set of participant-centered measures that evaluates and monitors the physical, mental, and social health in adults. Although unknown in osteoarthritis, the PROMIS® 10 Global Heath Survey was developed by the National Institute of Health and validated across a variety of chronic conditions. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable". | Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the ankle using SF-12v2 | The SF-12v2 is a generic health outcome measurement widely used in chronic illness and chronic pain conditions. The SF-12v2 is a shorter tool that requires less patient and provider effort. Validity and feasibility have been reviewed with demonstration for significance in non-cancer pain patients. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. SF-12v2 patient-reported questionnaire is utilizes a 5-point scale ranging from "Excellent"/"All of the time" to "None of the time"/"Poor" for both physical and mental questions as well as a 3-point score ranging from "Yes, limited a lot" to "No, not limited at all" for two physical questions | Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the ankle using the Pain Score on Visual Analog (VAS-Pain) | VAS instrument measures a characteristic that spans a continuum, cannot be precisely or optimally measured by or would lack sensitivity in distinguishing subtle changes on an ordinal scale. Pain intensity is a characteristic that is Sanford Health Confidential commonly measured in this manner. A 100-mm VAS will be administered to assess the subject's experience of joint pain intensity. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The visual analog scale (VAS) patient-reported questionnaire is a subjective measure for acute and chronic pain utilizing a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain". | Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the ankle using the Foot and Ankle Disability Index (FADI) | The Foot and Ankle Disability Index (FADI) is a 34-item questionnaire divided into two sub-scales: the Foot and Ankle Disability Index and the Foot and Ankle Sports Disability index (Hale 2005). Although not one foot and ankle self-reported measure has been determined as the most reliable, FADI is designed to detect deficits in higher functioning subjects and is more sensitive to responses after deliberate intervention. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The FADI is a 34-item patient-reported questionnaire utilizing a 5-point scale ranging from 0% (most disability) to 100% (least disability), e.g. 0="Unable to do"/"Unbearable" to 4="No difficulty"/"No Pain". | Through study completion, up to 3 years |
| Efficacy outcomes include changes in the range of motion of the ankle (ROM) | Ranges include: 0-40 degrees plantar flexion 0-20 degrees dorsiflexion 0-30 degrees inversion 0-20 degrees eversion | Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the hip using PROMIS 10 Global health | The PROMIS® is a set of participant-centered measures that evaluates and monitors the physical, mental, and social health in adults. Although unknown in osteoarthritis, the PROMIS® 10 Global Heath Survey was developed by the National Institute of Health and validated across a variety of chronic conditions. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable". | Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the hip using SF-12v2 | The SF-12v2 is a generic health outcome measurement widely used. The Bonferroni adjustment for multiple testing correction will be used within each cohort. SF-12v2 patient-reported questionnaire is utilizes a 5-point scale ranging from "Excellent"/"All of the time" to "None of the time"/"Poor" for both physical and mental questions as well as a 3-point score ranging from "Yes, limited a lot" to "No, not limited at all" for two physical questions. The PROMIS Global-10 is a 10-item patient-reported questionnaire utilizing as 5-point Global Physical Health Score scale ranging from 5="Excellent/Completely" to 1="Poor/Not at all" and a 5-point Global Mental Health scale ranging from 5="Never/None" to 1="Always/Very Severe", as well as a single 11-point question scale from 0="No Pain" to 10="Worst Pain Imaginable". | Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the hip using Pain Score on Visual Analog Scale (VAS-Pain) | A VAS instrument measures a characteristic that spans a continuum, cannot be precisely or optimally measured by or would lack sensitivity in distinguishing subtle changes on an ordinal scale. Pain intensity is a characteristic that is commonly measured in this manner. A 100-mm VAS will be administered to assess the subject's experience of joint pain intensity. Each efficacy measure will be analyzed separately while accounting for potential confounding factors in the model such as age, sex, BMI, severity of OA diagnosis, smoking status, and past treatments in targeted joint. The Bonferroni adjustment for multiple testing correction will be used within each cohort. The visual analog scale (VAS) patient-reported questionnaire is a subjective measure for acute and chronic pain utilizing a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain". | Through study completion, up to 3 years |
| Efficacy outcomes include changes in patient reported outcomes (PRO) measurements for the hip using the Hip Disability Osteoarthritis Outcome Score (HOOS) | The HOOS is a patient-administered questionnaire consisting of 40 items across five subscales: Pain (10 items), Symptoms (5 items), Activity of Daily Living (17 items), Sport and Recreation Function (4 items) and Hip Related Quality of Life (4 items). The HOOS is scored on a Likert scale of 0 to 4 (no, mild, moderate, severe and extreme) with a total score is calculated by using a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms, with higher scores representing better function. | Through study completion, up to 3 years |
| Efficacy outcomes include changes in the range of motion of the knee (ROM) measurements for the hip | Ranges include: 0-125 degrees flexion 115-0 degrees extension 0-15 degrees hyperextension 0-45 degrees abduction 0-20 degrees adduction | Through study completion, up to 3 years |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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