OsteoarthritisNCT04191733
Anterior Advantage With KINCISE
A study testing KINCISE(TM) Surgical Automated System in people with Osteoarthritis and Rheumatoid Arthritis, run by DePuy Orthopaedics at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Post Traumatic Arthritis
- What is being tested?
- KINCISE(TM) Surgical Automated System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 11 sitesUnited States
- Study dates
- 28 Jan 2020to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Capital Region Orthopaedic Group
Albany, New York, 12208
Texas Institute for Hip and Knee Surgery
Austin, Texas, 78751
W.B. Carrell Memorial Clinic
Dallas, Texas, 75231
North Texas Medical Research Institute
Dallas, Texas, 75254
Colorado Joint Replacement
Denver, Colorado, 80210
Carolina Orthopaedic & Sports Medicine
Gastonia, North Carolina, 28054
Southern Joint Replacement Institute
Nashville, Tennessee, 37203
Hospital for Special Surgery
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
The Orthopedic Specialty Center of Northern California
Roseville, California, 95678
Jordan-Young Institute
Virginia Beach, Virginia, 23462
About this study
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.
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.
Read the 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)
- Being tested
- KINCISE(TM) Surgical Automated System
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KINCISE(TM) Surgical Automated SystemDevice
Uncemented Total Hip Arthroplasty via Anterior Approach with and without the KINCISE(TM) Surgical Automated System
| Study group | Role | What they receive |
|---|---|---|
| Anterior Approach with KINCISE | Experimental | Anterior Approach THA using KINCISE(TM) Surgical Automated System Receives: Device: KINCISE(TM) Surgical Automated System |
| Anterior Approach without KINCISE | Active comparator | Anterior Approach THA with a mallet (without KINCISE) Receives: Device: KINCISE(TM) Surgical Automated System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 (operative day)
Secondary outcomes (19)
Skin-to-skin Time
Skin-to-skin is the time (in minutes) duration of the surgery procedure.
Measured: Day 0 (operative day)
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.
Measured: At Week 6 (post operative)
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.
Measured: At Week 6 (post operative)
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.
Measured: Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative
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).
Measured: 6-week post-operative to 24 weeks post-operatively
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.
Measured: Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative
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.
Measured: Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative
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.
Measured: Weeks 6 and 24 (post-operative)
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.
Measured: Weeks 6 and 24 (post-operative)
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.
Measured: Week 6 (post-operative)
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.
Measured: Weeks 6 and 24 (post-operative)
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.
Measured: Weeks 6 and 24 (post-operative)
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.
Measured: Weeks 6 and 24 (post-operative)
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."
Measured: Weeks 6 and 24 (post-operative)
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.
Measured: Weeks 6 and 24 (post-operative)
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.
Measured: From operative day (Day 0) to date of discharge (any time from Day 0 to Day 5)
Number of Participants With Re-hospitalization During the Study
Number of participants with re-hospitalizations during the study was reported.
Measured: Day 0 (operative day) to Day 90 (post-operative)
Number of Participants With Narcotic Pain Medication Usage
Number of participants who received any narcotic pain medication to manage study hip pain was reported.
Measured: From post operation (Day 0) to Week 24
Number of Participants With Post-operative Complications
Number of participants who experienced post-operative complication was reported.
Measured: Day 0 (operative day) up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start28 Jan 2020
- Primary completion13 Jul 2022
- Study completion31 Aug 2022
Why it stopped: Sponsor terminated study early. Data collection was sufficient to adequately assess primary endpoint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 Block Randomization
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191733
- Sponsor's protocol ID
- DSJ_2019_03
- Status last verified
- Sep 2023
- First submitted
- 28 Oct 2019
- Last updated
- 15 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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/
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04191733
- Acronym / sponsor ID
- DSJ_2019_03
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor terminated study early. Data collection was sufficient to adequately assess primary endpoint.
- Enrolment
- 250 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Posted 15 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 Block Randomization
| Arm | Type | Receives |
|---|---|---|
| Anterior Approach with KINCISE | Experimental | Device: KINCISE(TM) Surgical Automated SystemAnterior Approach THA using KINCISE(TM) Surgical Automated System |
| Anterior Approach without KINCISE | Active comparator | Device: KINCISE(TM) Surgical Automated SystemAnterior Approach THA with a mallet (without KINCISE) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KINCISE(TM) Surgical Automated SystemUncemented Total Hip Arthroplasty via Anterior Approach with and without the KINCISE(TM) Surgical Automated System | Device | Anterior Approach with KINCISE, Anterior Approach without KINCISE |
Primary outcome
Mean Femoral Broach Time
Time frame: Day 0 (operative day)
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.
19 secondary outcomes
Skin-to-skin Time
Time frame: Day 0 (operative day)
Number of Participants With Optimal Acetabular Cup Abduction Angle at Week 6
Time frame: At Week 6 (post operative)
Number of Participants With Optimal Acetabular Cup Version Angle at Week 6
Time frame: At Week 6 (post operative)
Change From Pre-operative Baseline in Harris Hip Score (HHS) at Weeks 6 and 24
Time frame: Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative
Change From 6-week Post-surgery in Forgotten Joint Score (FJS-12) at Week 24
Time frame: 6-week post-operative to 24 weeks post-operatively
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
Time frame: Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative
Change From Pre-operative Baseline in EQ-5D-5L Visual Analog Scale (VAS) Total Score at Weeks 6 and 24
Time frame: Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24
Time frame: Weeks 6 and 24 (post-operative)
Number of Participants With Post-operative Satisfaction With the Procedure at Weeks 6 and 24
Time frame: Weeks 6 and 24 (post-operative)
Number of Participants With Post-operative Functional Recovery at Week 6
Time frame: Week 6 (post-operative)
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur
Time frame: Weeks 6 and 24 (post-operative)
Number of Participants With Radiographic Outcomes: Femoral Stem Position
Time frame: Weeks 6 and 24 (post-operative)
Number of Participants With Radiographic Outcomes: Device/Anatomy Condition
Time frame: Weeks 6 and 24 (post-operative)
Number of Participants With Radiographic Outcomes: Heterotopic Ossification
Time frame: Weeks 6 and 24 (post-operative)
Radiographic Outcomes: Assessment of Acetabular Cup Version (Hip) and Acetabular Cup Inclination
Time frame: Weeks 6 and 24 (post-operative)
Length of Hospital Stay After Index Total Hip Arthroplasty (THA)
Time frame: From operative day (Day 0) to date of discharge (any time from Day 0 to Day 5)
Number of Participants With Re-hospitalization During the Study
Time frame: Day 0 (operative day) to Day 90 (post-operative)
Number of Participants With Narcotic Pain Medication Usage
Time frame: From post operation (Day 0) to Week 24
Number of Participants With Post-operative Complications
Time frame: Day 0 (operative day) up to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KINCISE(TM) Surgical Automated System in people with Osteoarthritis and Rheumatoid Arthritis, run by DePuy Orthopaedics at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Femoral Broach Time (time frame: Day 0 (operative day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023; AzTrials last refreshed its copy on 31 Oct 2026.