Back to resultsAnterior Advantage With KINCISE
Primary Purpose
Osteoarthritis, Rheumatoid Arthritis, Post Traumatic Arthritis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KINCISE(TM) Surgical Automated System
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- The patient is undergoing a standard of care primary cementless hip replacement with the Pinnacle cup and a Corail or Actis stem via the Anterior Advantage approach. All devices are to be used according to the approved indications.
- Individuals who are able to speak, read, and comprehend the Institutional Review Board approved Informed Consent Document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of his/her information to DePuy Synthes.
- Individuals who are willing and able to complete follow-up visits and questionnaires as specified by the study protocol.
- Individuals who are not bedridden per the discretion of the investigator (The intent of "not bedridden" means a permanent situation, not a temporary situation as in a hip fracture or trauma case).
- Individuals who are a minimum age of 21 years at the time of consent.
Exclusion Criteria:
- Active local or systemic infection.
- Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
- Poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).
- Charcot's or Paget's disease.
- The Subject is a woman who is pregnant or lactating.
- Subject had a contralateral amputation.
- Previous partial hip replacement in affected hip.
- Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
- Contralateral hip was replaced less than 3 months prior to surgery date, contralateral hip is already enrolled in the study, or simultaneous or staged hip replacement is planned
- Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
- Subject has a medical condition with less than 2 years of life expectancy.
- Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has a physical or psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
Sites / Locations
- The Orthopedic Specialty Center of Northern California
- Colorado Joint Replacement
- Capital Region Orthopaedic Group
- Hospital for Special Surgery
- Columbia University Medical Center
- Carolina Orthopaedic & Sports Medicine
- Southern Joint Replacement Institute
- Texas Institute for Hip and Knee Surgery
- W.B. Carrell Memorial Clinic
- North Texas Medical Research Institute
- Jordan-Young Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Anterior Approach with KINCISE
Anterior Approach without KINCISE
Arm Description
Anterior Approach THA using KINCISE(TM) Surgical Automated System
Anterior Approach THA with a mallet (without KINCISE)
Outcomes
Primary Outcome Measures
Mean Femoral Broach Time
Mean femoral broach time (in minutes) was collected intraoperatively and begun at the time the box osteotome first enters the femoral canal and ended with seating of the final broach trial within the femoral canal.
Secondary Outcome Measures
Skin-to-skin Time
Skin-to-skin is the time (in minutes) duration of the surgery procedure.
Number of Participants With Optimal Acetabular Cup Abduction Angle at Week 6
Number of participants with optimal acetabular cup (a socket of the hip joint) abduction angle (movement of the leg away from the midline of the body) within +/- 10 degree of plan at Week 6 was reported.
Number of Participants With Optimal Acetabular Cup Version Angle at Week 6
Number of participants with optimal acetabular cup (a socket of the hip joint) version angle (rotation of leg in hip joint) within +/- 10 degrees of plan at Week 6 was reported.
Change From Pre-operative Baseline in Harris Hip Score (HHS) at Weeks 6 and 24
The HHS was developed for the assessment of the results of hip surgery. HHS was intended to evaluate various hip disabilities and methods of treatment in an adult population. It consisted of 10 items covering four domains: pain (1 item, 0-44 points), function ( 7 items [limb, support, distance walked, stairs, socks/shoes, sitting and public transportation], 0-47 points), deformity (1 item, 4 points) and range of hip motion (1 items, 5 points). HHS total score was the sum of 10 items scores and ranged from 0 (worse disability) to 100 (less disability). The higher score indicated better outcome for the participant. The scores were interpreted as follows: < 70 = poor, 70-79 = fair, 80-89 = good and 90-100 = excellent. Day 0 was the operative day.
Change From 6-week Post-surgery in Forgotten Joint Score (FJS-12) at Week 24
The FJS was a 12 question form that asks the participants their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Response to each question was individually scored (0 to 4, where 0=never, 1=almost never, 2=seldom, 3=sometimes and 4=mostly) and summed to create a raw composite score that was normalized to a range of 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the artificial joint in everyday life).
Change From Pre-operative Baseline in European Quality of Life (EuroQol)-5 Dimension-5 Level (EQ-5D-5L) Heath State Index Total Score at Weeks 6 and 24
EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D-5L dimensions were scored using a utility-weighted algorithm to derive an EQ-5D-5L health status index score between 0 (death) to 100 (full health). Higher score indicated better QoL.
Change From Pre-operative Baseline in EQ-5D-5L Visual Analog Scale (VAS) Total Score at Weeks 6 and 24
EQ-5D-5L was a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status.
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24
Number of participants with pain (Groin, and Buttock) at Weeks 6 and 24 was reported. Participant's groin pain and buttock pain was reported either as none, mild, moderate, or severe.
Number of Participants With Post-operative Satisfaction With the Procedure at Weeks 6 and 24
Number of participants with post-operative satisfaction with the procedure at Weeks 6 and 24 was reported. Participants were asked a question that "How satisfied do you anticipate you will be with this procedure?" and participant responded on a 5-point scale (1=extremely satisfied, 2=very satisfied, 3=moderately satisfied, 4=slightly satisfied, 5=not at all satisfied). Higher score indicated low post-operative satisfaction.
Number of Participants With Post-operative Functional Recovery at Week 6
Participants were asked the following questions: "Can you walk without an aid?", "Do you drive?", "Can you perform basic activities of daily living without assistance?", "Can you perform light household duties?", "Can you perform moderate to heavy household duties?", "Can you go up and down a flight of stairs using a handrail?", "Can you put on socks/stockings without someone's assistance?", "Can you bend down to pick up an object on the floor?", "Can you stand up from a chair without assistance?", "Can you participate in leisure recreational activities?", "Do you work?" and "When were you first able to accomplish the primary goal you identified after surgery?". Participants were asked to respond either as "yes" or "No, because of study hip". Number of participants who reported response as "yes" at Week 6 were reported in this outcome measure.
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur
Number of participants with radiographic outcomes (acetabular cup migration, acetabular cup radiolucency, acetabular cup progressive radiolucency, acetabular cup osteolysis, acetabular cup sclerotic lines, acetabular cup porous coating integrity, femoral stem subsidence, femoral stem radiolucency, femoral stem osteolysis, calcar resorption, calcar fracture, femoral stem tilt and femoral stem porous coating integrity) were reported. In this outcome measure, only those timepoints in which participants had data were reported. In this outcome measure, each radiographic outcome assessment was reported either as present or absent in the analyzed participants.
Number of Participants With Radiographic Outcomes: Femoral Stem Position
Number of participants with radiographic outcome (femoral stem position) were reported. Femoral stem position was assessed as neutral, varus and valgus.
Number of Participants With Radiographic Outcomes: Device/Anatomy Condition
Number of participants with radiographic outcome (device/anatomy condition) were reported. Assessments were reported as intact or not intact.
Number of Participants With Radiographic Outcomes: Heterotopic Ossification
Number of participants with radiographic outcome (heterotopic ossification) were reported. Ossification is defined as formation of extraskeletal bone in muscle and soft tissues. Heterotopic ossification is the presence of bone in soft tissue where bone normally does not exist. Heterotopic ossification was classified as Class 0, I, II, III and IV where Class 0 indicates "no evidence heterotopic bone formation", Class I indicates "islands of bone within the soft tissue about the hip", Class II indicates "bone spurs from the pelvis or proximal end of the femur, leaving at least a centimeter (cm) between opposing bone surfaces", Class III indicates "bone spurs from the pelvis or proximal end of the femur, reducing the space between opposing bone surfaces to less than 1 cm", and Class IV indicates "apparent bone ankylosis of the hip."
Radiographic Outcomes: Assessment of Acetabular Cup Version (Hip) and Acetabular Cup Inclination
Radiographic outcome was assessed on acetabular cup version (hip) and acetabular cup inclination and reported in this outcome measure.
Length of Hospital Stay After Index Total Hip Arthroplasty (THA)
Length of hospital stay (in days) after index THA was calculated from date of discharge minus date of surgery.
Number of Participants With Re-hospitalization During the Study
Number of participants with re-hospitalizations during the study was reported.
Number of Participants With Narcotic Pain Medication Usage
Number of participants who received any narcotic pain medication to manage study hip pain was reported.
Number of Participants With Post-operative Complications
Number of participants who experienced post-operative complication was reported.
Full Information
NCT ID
NCT04191733
First Posted
October 28, 2019
Last Updated
September 11, 2023
Sponsor
DePuy Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT04191733
Brief Title
Anterior Advantage With KINCISE
Official Title
Prospective, Randomized, Multi-center Post-Market Study of Anterior Advantage Surgical Approach in Total Hip Arthroplasty With and Without the KINCISE™ Surgical Automated System.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor terminated study early. Data collection was sufficient to adequately assess primary endpoint.
Study Start Date
January 28, 2020 (Actual)
Primary Completion Date
July 13, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a post-market prospective, 1:1 randomized, multicenter non-inferiority study to compare the femoral broaching time for THA with the Anterior Advantage approach with KINCISE vs. without KINCISE. Follow-up will continue through 24 weeks post-op.
Detailed Description
The primary endpoint is femoral broaching time (in minutes), which is collected intraoperatively. The primary objective is to demonstrate that femoral broaching time with KINCISE is non-inferior to femoral broaching time with manual instruments (not using KINCISE) when used in THA with Anterior Advantage.
Note: If non-inferiority is successfully demonstrated, then the study will be deemed to be successful, and a test for superiority of femoral broaching time will be conducted.
If the primary endpoint analysis successfully demonstrates non-inferiority of femoral broaching time, then the following three secondary objectives will be assessed with formal hypotheses, in order, under a gatekeeping strategy:
Non-inferiority of skin-to-skin OR time when KINCISE is used vs. when KINCISE is not used.
Non-inferiority of the percent of subjects with optimal acetabular cup abduction angle when KINCISE is used vs. when KINCISE is not used.
Non-inferiority of the percent of subjects with optimal acetabular cup version angle when KINCISE is used vs. when KINCISE is not used.
In addition, the following secondary endpoints do not have prospectively planned hypotheses; these will be summarized for both treatment groups:
Harris Hip Score (HHS) and HHS change from preoperative baseline
Forgotten Joint Score (FJS) and FJS change from 6-week postoperative baseline
EQ-5D-5L and changes in these assessments from preoperative baseline
Pain (Groin, Thigh, and Buttock)
Patient Satisfaction
Post-op time when functional activities can be accomplished (return to work, self-care, etc.)
Radiographic Outcomes (based upon AP Hip, AP Pelvis, and Lateral)
Length of hospital stay after index THA
Re-hospitalizations during the study (including a specific summary of re-hospitalizations within 90 days)
Narcotic drug usage throughout the study (participant reported)
Complications (including a specific summary of complications within 90 days post-surgery)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Rheumatoid Arthritis, Post Traumatic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 Block Randomization
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anterior Approach with KINCISE
Arm Type
Experimental
Arm Description
Anterior Approach THA using KINCISE(TM) Surgical Automated System
Arm Title
Anterior Approach without KINCISE
Arm Type
Active Comparator
Arm Description
Anterior Approach THA with a mallet (without KINCISE)
Intervention Type
Device
Intervention Name(s)
KINCISE(TM) Surgical Automated System
Intervention Description
Uncemented Total Hip Arthroplasty via Anterior Approach with and without the KINCISE(TM) Surgical Automated System
Primary Outcome Measure Information:
Title
Mean Femoral Broach Time
Description
Mean femoral broach time (in minutes) was collected intraoperatively and begun at the time the box osteotome first enters the femoral canal and ended with seating of the final broach trial within the femoral canal.
Time Frame
Day 0 (operative day)
Secondary Outcome Measure Information:
Title
Skin-to-skin Time
Description
Skin-to-skin is the time (in minutes) duration of the surgery procedure.
Time Frame
Day 0 (operative day)
Title
Number of Participants With Optimal Acetabular Cup Abduction Angle at Week 6
Description
Number of participants with optimal acetabular cup (a socket of the hip joint) abduction angle (movement of the leg away from the midline of the body) within +/- 10 degree of plan at Week 6 was reported.
Time Frame
At Week 6 (post operative)
Title
Number of Participants With Optimal Acetabular Cup Version Angle at Week 6
Description
Number of participants with optimal acetabular cup (a socket of the hip joint) version angle (rotation of leg in hip joint) within +/- 10 degrees of plan at Week 6 was reported.
Time Frame
At Week 6 (post operative)
Title
Change From Pre-operative Baseline in Harris Hip Score (HHS) at Weeks 6 and 24
Description
The HHS was developed for the assessment of the results of hip surgery. HHS was intended to evaluate various hip disabilities and methods of treatment in an adult population. It consisted of 10 items covering four domains: pain (1 item, 0-44 points), function ( 7 items [limb, support, distance walked, stairs, socks/shoes, sitting and public transportation], 0-47 points), deformity (1 item, 4 points) and range of hip motion (1 items, 5 points). HHS total score was the sum of 10 items scores and ranged from 0 (worse disability) to 100 (less disability). The higher score indicated better outcome for the participant. The scores were interpreted as follows: < 70 = poor, 70-79 = fair, 80-89 = good and 90-100 = excellent. Day 0 was the operative day.
Time Frame
Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative
Title
Change From 6-week Post-surgery in Forgotten Joint Score (FJS-12) at Week 24
Description
The FJS was a 12 question form that asks the participants their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Response to each question was individually scored (0 to 4, where 0=never, 1=almost never, 2=seldom, 3=sometimes and 4=mostly) and summed to create a raw composite score that was normalized to a range of 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the artificial joint in everyday life).
Time Frame
6-week post-operative to 24 weeks post-operatively
Title
Change From Pre-operative Baseline in European Quality of Life (EuroQol)-5 Dimension-5 Level (EQ-5D-5L) Heath State Index Total Score at Weeks 6 and 24
Description
EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D-5L dimensions were scored using a utility-weighted algorithm to derive an EQ-5D-5L health status index score between 0 (death) to 100 (full health). Higher score indicated better QoL.
Time Frame
Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative
Title
Change From Pre-operative Baseline in EQ-5D-5L Visual Analog Scale (VAS) Total Score at Weeks 6 and 24
Description
EQ-5D-5L was a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status.
Time Frame
Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative
Title
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24
Description
Number of participants with pain (Groin, and Buttock) at Weeks 6 and 24 was reported. Participant's groin pain and buttock pain was reported either as none, mild, moderate, or severe.
Time Frame
Weeks 6 and 24 (post-operative)
Title
Number of Participants With Post-operative Satisfaction With the Procedure at Weeks 6 and 24
Description
Number of participants with post-operative satisfaction with the procedure at Weeks 6 and 24 was reported. Participants were asked a question that "How satisfied do you anticipate you will be with this procedure?" and participant responded on a 5-point scale (1=extremely satisfied, 2=very satisfied, 3=moderately satisfied, 4=slightly satisfied, 5=not at all satisfied). Higher score indicated low post-operative satisfaction.
Time Frame
Weeks 6 and 24 (post-operative)
Title
Number of Participants With Post-operative Functional Recovery at Week 6
Description
Participants were asked the following questions: "Can you walk without an aid?", "Do you drive?", "Can you perform basic activities of daily living without assistance?", "Can you perform light household duties?", "Can you perform moderate to heavy household duties?", "Can you go up and down a flight of stairs using a handrail?", "Can you put on socks/stockings without someone's assistance?", "Can you bend down to pick up an object on the floor?", "Can you stand up from a chair without assistance?", "Can you participate in leisure recreational activities?", "Do you work?" and "When were you first able to accomplish the primary goal you identified after surgery?". Participants were asked to respond either as "yes" or "No, because of study hip". Number of participants who reported response as "yes" at Week 6 were reported in this outcome measure.
Time Frame
Week 6 (post-operative)
Title
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur
Description
Number of participants with radiographic outcomes (acetabular cup migration, acetabular cup radiolucency, acetabular cup progressive radiolucency, acetabular cup osteolysis, acetabular cup sclerotic lines, acetabular cup porous coating integrity, femoral stem subsidence, femoral stem radiolucency, femoral stem osteolysis, calcar resorption, calcar fracture, femoral stem tilt and femoral stem porous coating integrity) were reported. In this outcome measure, only those timepoints in which participants had data were reported. In this outcome measure, each radiographic outcome assessment was reported either as present or absent in the analyzed participants.
Time Frame
Weeks 6 and 24 (post-operative)
Title
Number of Participants With Radiographic Outcomes: Femoral Stem Position
Description
Number of participants with radiographic outcome (femoral stem position) were reported. Femoral stem position was assessed as neutral, varus and valgus.
Time Frame
Weeks 6 and 24 (post-operative)
Title
Number of Participants With Radiographic Outcomes: Device/Anatomy Condition
Description
Number of participants with radiographic outcome (device/anatomy condition) were reported. Assessments were reported as intact or not intact.
Time Frame
Weeks 6 and 24 (post-operative)
Title
Number of Participants With Radiographic Outcomes: Heterotopic Ossification
Description
Number of participants with radiographic outcome (heterotopic ossification) were reported. Ossification is defined as formation of extraskeletal bone in muscle and soft tissues. Heterotopic ossification is the presence of bone in soft tissue where bone normally does not exist. Heterotopic ossification was classified as Class 0, I, II, III and IV where Class 0 indicates "no evidence heterotopic bone formation", Class I indicates "islands of bone within the soft tissue about the hip", Class II indicates "bone spurs from the pelvis or proximal end of the femur, leaving at least a centimeter (cm) between opposing bone surfaces", Class III indicates "bone spurs from the pelvis or proximal end of the femur, reducing the space between opposing bone surfaces to less than 1 cm", and Class IV indicates "apparent bone ankylosis of the hip."
Time Frame
Weeks 6 and 24 (post-operative)
Title
Radiographic Outcomes: Assessment of Acetabular Cup Version (Hip) and Acetabular Cup Inclination
Description
Radiographic outcome was assessed on acetabular cup version (hip) and acetabular cup inclination and reported in this outcome measure.
Time Frame
Weeks 6 and 24 (post-operative)
Title
Length of Hospital Stay After Index Total Hip Arthroplasty (THA)
Description
Length of hospital stay (in days) after index THA was calculated from date of discharge minus date of surgery.
Time Frame
From operative day (Day 0) to date of discharge (any time from Day 0 to Day 5)
Title
Number of Participants With Re-hospitalization During the Study
Description
Number of participants with re-hospitalizations during the study was reported.
Time Frame
Day 0 (operative day) to Day 90 (post-operative)
Title
Number of Participants With Narcotic Pain Medication Usage
Description
Number of participants who received any narcotic pain medication to manage study hip pain was reported.
Time Frame
From post operation (Day 0) to Week 24
Title
Number of Participants With Post-operative Complications
Description
Number of participants who experienced post-operative complication was reported.
Time Frame
Day 0 (operative day) up to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient is undergoing a standard of care primary cementless hip replacement with the Pinnacle cup and a Corail or Actis stem via the Anterior Advantage approach. All devices are to be used according to the approved indications.
Individuals who are able to speak, read, and comprehend the Institutional Review Board approved Informed Consent Document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of his/her information to DePuy Synthes.
Individuals who are willing and able to complete follow-up visits and questionnaires as specified by the study protocol.
Individuals who are not bedridden per the discretion of the investigator (The intent of "not bedridden" means a permanent situation, not a temporary situation as in a hip fracture or trauma case).
Individuals who are a minimum age of 21 years at the time of consent.
Exclusion Criteria:
Active local or systemic infection.
Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
Poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).
Charcot's or Paget's disease.
The Subject is a woman who is pregnant or lactating.
Subject had a contralateral amputation.
Previous partial hip replacement in affected hip.
Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
Contralateral hip was replaced less than 3 months prior to surgery date, contralateral hip is already enrolled in the study, or simultaneous or staged hip replacement is planned
Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
Subject has a medical condition with less than 2 years of life expectancy.
Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has a physical or psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
Facility Information:
Facility Name
The Orthopedic Specialty Center of Northern California
City
Roseville
State/Province
California
ZIP/Postal Code
95678
Country
United States
Facility Name
Colorado Joint Replacement
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Capital Region Orthopaedic Group
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Carolina Orthopaedic & Sports Medicine
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Southern Joint Replacement Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Institute for Hip and Knee Surgery
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Facility Name
W.B. Carrell Memorial Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
North Texas Medical Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75254
Country
United States
Facility Name
Jordan-Young Institute
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu/
IPD Sharing URL
http://yoda.yale.edu/
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Anterior Advantage With KINCISE
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