Osteoarthritis, KneeNCT03093077
Kinematics After Total Knee Arthroplasty
A study testing DePuy ATTUNE total knee arthroplasty system in people with Osteoarthritis, Knee, run by Kristin Zhao, PhD at 1 site in United States.
Trial summary
The purpose of this study is to evaluate and compare implant kinematics of conventional mechanically aligned and anatomically aligned total knee arthroplasties (TKA) at 1 year post-operatively. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- DePuy ATTUNE total knee arthroplasty system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 10 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females
- Primary arthroplasty for treatment of osteoarthritis
- Age between 40 and 80 years old
- Willingness to provide written consent for study participation
Who cannot join
- Revision arthroplasty
- Pre-operative knee flexion lower than 90 degrees
- Varus knee deformity greater than 15 degrees
- Pre-operative valgus knee deformity
- Presence of infections, highly communicable diseases or metastatic disease
- Significant neurological or musculoskeletal disorders or disease that may interfere with normal gait or weight bearing
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- Congenital, developmental, or other bone disease or previous hip surgery that may, in the surgeon's judgment, interfere with total knee prosthesis survival or success
- Presence of previous prosthetic knee or hip replacement device
- BMI > 40
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Kinematics Following Total Knee Arthroplasty Performed With Different Surgical Alignment Techniques
The purpose of this study is to evaluate and compare implant kinematics of conventional mechanically aligned and anatomically aligned total knee arthroplasties (TKA) at 1 year post-operatively.
Read the detailed description
Participants will be randomized to receive a primary TKA using either an anatomic alignment or a conventional mechanical alignment technique.
Participants will undergo a kinematic analysis of a deep knee bend using single-plane fluoroscopy at 1 year post-operatively. The primary outcome will be based on the 6 degree of freedom kinematics and associated joint component proximity during the knee bend task. Secondary outcomes include the Knee Society Score, the Knee Injury and Osteoarthritis Outcome Score, and the Forgotten Knee Score.
- Conditions
- Osteoarthritis, Knee
- Being tested
- DePuy ATTUNE total knee arthroplasty system
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DePuy ATTUNE total knee arthroplasty systemDevice
A standard midvastus approach will be used for both alignment technique groups. This is a standard approach for exposing the knee joint for TKA.
| Study group | Role | What they receive |
|---|---|---|
| Anatomic alignment | Experimental | The aim of anatomic alignment is to recreate an individual's pre-operative alignment using the DePuy ATTUNE total knee arthroplasty system. Receives: Device: DePuy ATTUNE total knee arthroplasty system |
| Mechanical alignment | Active comparator | The aim of mechanical alignment is to achieve a neutral mechanical alignment regardless of pre-operative status, using the DePuy ATTUNE total knee arthroplasty system. Receives: Device: DePuy ATTUNE total knee arthroplasty system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee motion, as determined by 6 degree freedom of movement kinematics and associated joint proximity during the knee bend task.
Measured: 1 year post surgery
Secondary outcomes (3)
Participants perception of knee function, as determined by the Knee injury Osteoarthritis Outcome Score (KOOS)
Measured: 1 year post surgery
Participant's awareness of the joint implant, as determined by the Forgotten Joint Score (FJS-12)
Measured: 1 year post surgery
Knee joint and ambulatory function based on physical exam, as determined by the Knee Society Score (KSS)
Measured: 1 year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study startNov 2016
- Primary completion10 Apr 2018
- Study completion10 Apr 2018
Why it stopped: Unanswered questions regarding indications for device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristin Zhao, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristin Zhao, PhD, Mayo Clinic
- Investigators
- Kristin D. Zhao, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093077
- Sponsor's protocol ID
- 15-008300
- Status last verified
- Apr 2018
- First submitted
- 26 Sep 2016
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinematics Following Total Knee Arthroplasty Performed With Different Surgical Alignment Techniques
- ClinicalTrials.gov ID
- NCT03093077
- Acronym / sponsor ID
- 15-008300
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unanswered questions regarding indications for device.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kristin Zhao, PhDUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate and compare implant kinematics of conventional mechanically aligned and anatomically aligned total knee arthroplasties (TKA) at 1 year post-operatively.
Detailed description
Participants will be randomized to receive a primary TKA using either an anatomic alignment or a conventional mechanical alignment technique.
Participants will undergo a kinematic analysis of a deep knee bend using single-plane fluoroscopy at 1 year post-operatively. The primary outcome will be based on the 6 degree of freedom kinematics and associated joint component proximity during the knee bend task. Secondary outcomes include the Knee Society Score, the Knee Injury and Osteoarthritis Outcome Score, and the Forgotten Knee Score.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anatomic alignment | Experimental | Device: DePuy ATTUNE total knee arthroplasty systemThe aim of anatomic alignment is to recreate an individual's pre-operative alignment using the DePuy ATTUNE total knee arthroplasty system. |
| Mechanical alignment | Active comparator | Device: DePuy ATTUNE total knee arthroplasty systemThe aim of mechanical alignment is to achieve a neutral mechanical alignment regardless of pre-operative status, using the DePuy ATTUNE total knee arthroplasty system. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females
- Primary arthroplasty for treatment of osteoarthritis
- Age between 40 and 80 years old
- Willingness to provide written consent for study participation
Key exclusion criteria (10 listed)
- Revision arthroplasty
- Pre-operative knee flexion lower than 90 degrees
- Varus knee deformity greater than 15 degrees
- Pre-operative valgus knee deformity
- Presence of infections, highly communicable diseases or metastatic disease
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 |
|---|---|---|
| DePuy ATTUNE total knee arthroplasty systemA standard midvastus approach will be used for both alignment technique groups. This is a standard approach for exposing the knee joint for TKA. | Device | Anatomic alignment, Mechanical alignment |
Primary outcome
Knee motion, as determined by 6 degree freedom of movement kinematics and associated joint proximity during the knee bend task.
Time frame: 1 year post surgery
3 secondary outcomes
Participants perception of knee function, as determined by the Knee injury Osteoarthritis Outcome Score (KOOS)
Time frame: 1 year post surgery
Participant's awareness of the joint implant, as determined by the Forgotten Joint Score (FJS-12)
Time frame: 1 year post surgery
Knee joint and ambulatory function based on physical exam, as determined by the Knee Society Score (KSS)
Time frame: 1 year post surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
Kristin D. Zhao, Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DePuy ATTUNE total knee arthroplasty system in people with Osteoarthritis, Knee, run by Kristin Zhao, PhD at 1 site 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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Knee motion, as determined by 6 degree freedom of movement kinematics and associated joint proximity during the knee bend task. (time frame: 1 year 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 25 Apr 2018.