OsteoarthritisSOLONCT02574312
ATTUNE Single-Use Instrumentation vs. ATTUNE Reusable Instrumentation in Primary Total Knee Arthroplasty
A study testing ATTUNE TKA with ATTUNE RUI and ATTUNE TKA with ATTUNE SUI in people with Osteoarthritis and Post-traumatic Arthritis, run by DePuy Orthopaedics at 4 sites in 2 countries.
Trial summary
This post-marketing investigation will evaluate the mechanical axis alignment achieved with the ATTUNE Single-Use Instrumentation (SUI) as compared to the mechanical axis alignment achieved with the ATTUNE Reusable Instrumentation (RUI) in primary cemented Total Knee Arthroplasty. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Osteoarthritis, Post-traumatic Arthritis
- What is being tested?
- ATTUNE TKA with ATTUNE RUI and ATTUNE TKA with ATTUNE SUI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Oct 2015to 28 Mar 2019
- 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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with severely painful and/or severely disabling Non-inflammatory Degenerative Joint Disease (NIDJD) resulting from osteoarthritis (OA) or post-traumatic arthritis.
- Subject is male or female and between the ages of 22 and 80 years old, inclusive.
- Subject requires a primary total knee replacement and is considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol.
- Subject, who, in the opinion of the Investigator, is suitable for implantation using either RUI or SUI instrumentation.
- Subject is able to speak and read English to facilitate comprehension of the Informed Consent Document.
- Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy Synthes Joint Reconstruction.
- Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures.
Who cannot join
- The Subject has, in the opinion of the Investigator, a severe deformity that will hinder achieving a mechanical axis alignment target of 0° ± 3°.
- The Subject has, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study.
- The Subject has, in the opinion of the Investigator, a flexion deformity that will not allow for 0° extension postoperatively.
- The Subject is a woman who is pregnant or lactating.
- The Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect follow-up care or treatment outcomes.
- The Subject has participated in a clinical investigation with an investigational product in the last 3 months.
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- The Subject is currently involved in any personal injury litigation, medical-legal or worker's compensations claims.
- The Subject has previous prosthetic knee replacement (any type including unicompartmental, total knee arthroplasty, patellofemoral arthroplasty or ipsilateral UTO/HTO) of the affected knee or a previous patellectomy.
- The Subject presents with ankylosis of the hip joint on the side to be treated.
- The Subject had a contralateral TKA and that knee was previously entered into the study.
- The Subject requires simultaneous bilateral total knee replacements.
- Any case in which Computer-Assisted Surgery (CAS) or TruMatch (or any other type of Custom Patient Instruments) is to be used, or any additional instrumentation are to be used for bone resections that are not provided as part of the ATTUNE RUI or SUI Instrument kits.
- The Subject requires a device not specified in the protocol or the surgeon determines that the ATTUNE Knee System is not a suitable treatment.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Scripps Clinic Torrey Pines
La Jolla, California, 92037
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, 18702
United Kingdom2 sites
Spire Liverpool Hospital
Liverpool, L18 1HQ
Clifton Park Hospital
York, YO30 5RA
About this study
Official title: Comparison of Alignment Achieved Using Single-Use Versus Reusable Instrumentation in Total Knee Arthroplasty (TKA): A Prospective, Non-Randomized Multi-center Investigation
This post-marketing investigation will evaluate the mechanical axis alignment achieved with the ATTUNE Single-Use Instrumentation (SUI) as compared to the mechanical axis alignment achieved with the ATTUNE Reusable Instrumentation (RUI) in primary cemented Total Knee Arthroplasty.
Read the detailed description
This study is designed as comparative, sequential, non-randomized, multi-center investigation.
Up to four sites will recruit approximately 88 subjects. Each site is expected to implant the ATTUNE primary cemented total knee in approximately 22 subjects. The sequential design requires all ATTUNE TKA with reusable instruments be completed before doing any ATTUNE TKA with single use instruments.
The mechanical axis alignment will be assessed at the 3 month follow-up by independent radiographic review.
- Conditions
- Osteoarthritis, Post-traumatic Arthritis
- Being tested
- ATTUNE TKA with ATTUNE RUI, ATTUNE TKA with ATTUNE SUI
- Keywords
- Mechanical Axis Alignment, Knee Arthroplasty, Total
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATTUNE TKA with ATTUNE RUIDevice
Also called ATTUNE Intuition
ATTUNE TKA with ATTUNE RUI
ATTUNE TKA with ATTUNE SUIDevice
Also called ATTUNE SOLO
ATTUNE TKA with ATTUNE SUI
| Study group | Role | What they receive |
|---|---|---|
| TKA with RUI | Active comparator | 44 Subjects will receive TKA with RUI per their study doctor's standard of care. These 44 subjects will receive the TKA using Reusable instruments (RUI). Receives: Device: ATTUNE TKA with ATTUNE RUI |
| TKA with SUI | Experimental | 44 Subjects will receive TKA with SUI per their study doctor's standard of care. These 44 subjects will receive the TKA using Single Use Instruments (SUI). Receives: Device: ATTUNE TKA with ATTUNE SUI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Absolute Mechanical Axis Alignment Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation
Measured: 3 Months Post Surgery
Secondary outcomes (5)
Femoral Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation
Measured: 3 Months Post Surgery
Tibial Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation
Measured: 3 Months Post Surgery
Femoral Component Flexion Angle Between Subjects Operated on With RUI and SUI Instrumentation
Measured: 3 Months Post Surgery
Posterior Tibial Slope Between Subjects Operated on With RUI and SUI Instrumentation
Measured: 3 Months Post Surgery
Number of Participants With Treatment-related Adverse Events
Measured: 3 Months Post Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study start1 Oct 2015
- Primary completion28 Mar 2019
- Study completion28 Mar 2019
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Verdonna Huey, MS,BSN,CCRP, Study director, DePuy Synthes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574312
- Sponsor's protocol ID
- 10002
- Acronym
- SOLO
- Status last verified
- Mar 2020
- First submitted
- 30 Sep 2015
- Last updated
- 9 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Alignment Achieved Using Single-Use Versus Reusable Instrumentation in Total Knee Arthroplasty (TKA): A Prospective, Non-Randomized Multi-center Investigation
- ClinicalTrials.gov ID
- NCT02574312
- Acronym / sponsor ID
- SOLO / 10002
- Conditions
- Osteoarthritis, Post-traumatic Arthritis
- Keywords
- Mechanical Axis Alignment, Knee Arthroplasty, Total
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Posted 9 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This post-marketing investigation will evaluate the mechanical axis alignment achieved with the ATTUNE Single-Use Instrumentation (SUI) as compared to the mechanical axis alignment achieved with the ATTUNE Reusable Instrumentation (RUI) in primary cemented Total Knee Arthroplasty.
Detailed description
This study is designed as comparative, sequential, non-randomized, multi-center investigation.
Up to four sites will recruit approximately 88 subjects. Each site is expected to implant the ATTUNE primary cemented total knee in approximately 22 subjects. The sequential design requires all ATTUNE TKA with reusable instruments be completed before doing any ATTUNE TKA with single use instruments.
The mechanical axis alignment will be assessed at the 3 month follow-up by independent radiographic review.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TKA with RUI | Active comparator | Device: ATTUNE TKA with ATTUNE RUI44 Subjects will receive TKA with RUI per their study doctor's standard of care. These 44 subjects will receive the TKA using Reusable instruments (RUI). |
| TKA with SUI | Experimental | Device: ATTUNE TKA with ATTUNE SUI44 Subjects will receive TKA with SUI per their study doctor's standard of care. These 44 subjects will receive the TKA using Single Use Instruments (SUI). |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with severely painful and/or severely disabling Non-inflammatory Degenerative Joint Disease (NIDJD) resulting from osteoarthritis (OA) or post-traumatic arthritis.
- Subject is male or female and between the ages of 22 and 80 years old, inclusive.
- Subject requires a primary total knee replacement and is considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol.
- Subject, who, in the opinion of the Investigator, is suitable for implantation using either RUI or SUI instrumentation.
- Subject is able to speak and read English to facilitate comprehension of the Informed Consent Document.
Key exclusion criteria (13 listed)
- The Subject has, in the opinion of the Investigator, a severe deformity that will hinder achieving a mechanical axis alignment target of 0° ± 3°.
- The Subject has, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study.
- The Subject has, in the opinion of the Investigator, a flexion deformity that will not allow for 0° extension postoperatively.
- The Subject is a woman who is pregnant or lactating.
- The Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect follow-up care or treatment outcomes.
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 |
|---|---|---|
| ATTUNE TKA with ATTUNE RUIAlso: ATTUNE IntuitionATTUNE TKA with ATTUNE RUI | Device | TKA with RUI |
| ATTUNE TKA with ATTUNE SUIAlso: ATTUNE SOLOATTUNE TKA with ATTUNE SUI | Device | TKA with SUI |
Primary outcome
Difference in Absolute Mechanical Axis Alignment Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation
Time frame: 3 Months Post Surgery
5 secondary outcomes
Femoral Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation
Time frame: 3 Months Post Surgery
Tibial Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation
Time frame: 3 Months Post Surgery
Femoral Component Flexion Angle Between Subjects Operated on With RUI and SUI Instrumentation
Time frame: 3 Months Post Surgery
Posterior Tibial Slope Between Subjects Operated on With RUI and SUI Instrumentation
Time frame: 3 Months Post Surgery
Number of Participants With Treatment-related Adverse Events
Time frame: 3 Months Post Surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Verdonna Huey, MS,BSN,CCRP study director
DePuy Synthes
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATTUNE TKA with ATTUNE RUI and ATTUNE TKA with ATTUNE SUI in people with Osteoarthritis and Post-traumatic Arthritis, run by DePuy Orthopaedics at 4 sites in 2 countries.
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 7 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: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, United Kingdom. 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 9 Apr 2020). 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?
Difference in Absolute Mechanical Axis Alignment Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation (time frame: 3 Months Post Surgery). 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 9 Apr 2020.