Complications; ArthroplastyNCT01882751
In Vivo Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant
An observational study of Complications; Arthroplasty, run by Restor3D at 2 sites in United States.
Trial summary
A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Complications; Arthroplasty
- What is being tested?
- Conformis CR Total Knee Replacement and Off the Shelf
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2013to Aug 2017
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are at least 6 month post-op with a ConforMIS knee replacement or a standard total knee replacement who meets the inclusion/exclusion criteria
Who may be able to join
- At least 6 months post-op
- Between 40-70 years of age
- Body weight of less than 250lbs
- TKA patients will be judged clinically successful with an American Knee Society score of greater than 90
- Must have post-op passive flexion of 100 degrees with no ligamentous laxity or pain
- Participants must be able to walk on level ground without aids and ascend/descend stairs without assistance.
- Subjects will either a ConforMIS™ TKA or a traditional TKA manufactured by any other orthopaedic company.
- Patients must be between 160cm (5'3) and 193cm (6'4) tall.
Who cannot join
- Subjects not willing to sign the Informed Consent and HIPAA forms to participate in the study
- BMI >40
- Pregnant females
- Surgical procedures conducted within the past 6 months other than TKA
- Subjects from the physician's list who do not meet study requirements
- Unwilling or unable to comply with study requirements
- Participation in another clinical study which would confound results
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tennessee Orthopaedic Clinics
Knoxville, Tennessee, 37923
University of Tennessee
Knoxville, Tennessee, 37996
About this study
Official title: In Vivo Determination & Comparison of Knee Kinematics for Subjects Implanted With Either a Personalized ConforMIS or Traditional Knee Implant
A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Previously, most experimental studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested the knee in a weight-bearing mode. Others have used exoskeletal linkages and skin markers that permit error due to undesired motions between markers and the underlying bone. More recently, fluoroscopy has been used to assess in vivo kinematics for subjects having a TKA.
ConforMIS has attempted to follow a clearly different path than the major orthopaedic companies. They have chosen to offer patients a personalized knee implant based off of each patient's femoral and tibial bone geometry. The hypothesis is that these subjects will experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding during weight-bearing knee flexion. Therefore, the objective for this study is to analyze the in vivo kinematics for 25 patients implanted with a personalized ConforMIS TKA and 25 patients implanted with a traditional TKA design to determine if there are any kinematic differences between these TKA designs.
Read the detailed description
Each subject will be asked to perform five activities in one continuous sequence: (1) stand up from a chair, (2) walk up stairs, (3) walk down stairs, (4) level walking, and (5) a deep knee bend. Subjects will be video recorded from the waist down while performing the activities. The speed level of each trial will be based on the comfort level of the patient. The fluoroscopic images will be stored digitally for subsequent analysis on secure servers and workstations at the University of Tennessee.
- Conditions
- Complications; Arthroplasty
- Being tested
- Conformis CR Total Knee Replacement, Off the Shelf
- Keywords
- kinematics, knee joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conformis CR Total Knee ReplacementDevice
iTotal CR by Conformis
Off the ShelfDevice
A standard knee replacement not using ConforMIS' iFit technology
| Study group | Role | What they receive |
|---|---|---|
| ConforMIS | Patients with ConforMIS implants Receives: Device: Conformis CR Total Knee Replacement | |
| Standard Total Knee Implant | Patients implanted with standard total knee implant Receives: Device: Off the Shelf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic Patterns during gait
There are multiple parameters captured by fluoroscopy that will be assessed during these 4 activities including:
- Anterior/posterior medial and lateral condyle contact positions
- Axial rotation of the femoral component relative to the tibial component
- Condylar lift-off will be determined by measuring the distances from the medial and lateral condyles to the polyethylene insert surface
- Weight-bearing range-of-motion.
Measured: at least 6 months post surgery
Kinematic patterns during deep knee bend
There are multiple parameters captured by fluoroscopy that will be assessed during these 4 activities including:
- Anterior/posterior medial and lateral condyle contact positions
- Axial rotation of the femoral component relative to the tibial component
- Condylar lift-off will be determined by measuring the distances from the medial and lateral condyles to the polyethylene insert surface
- Weight-bearing range-of-motion.
Measured: at least 6 months post surgery
Kinematics patterns during going up and down stairs
There are multiple parameters captured by fluoroscopy that will be assessed during these 4 activities including:
- Anterior/posterior medial and lateral condyle contact positions
- Axial rotation of the femoral component relative to the tibial component
- Condylar lift-off will be determined by measuring the distances from the medial and lateral condyles to the polyethylene insert surface
- Weight-bearing range-of-motion.
Measured: at least 6 months post surgery
Kinematics patterns during getting up from chair
There are multiple parameters captured by fluoroscopy that will be assessed during these 4 activities including:
- Anterior/posterior medial and lateral condyle contact positions
- Axial rotation of the femoral component relative to the tibial component
- Condylar lift-off will be determined by measuring the distances from the medial and lateral condyles to the polyethylene insert surface
- Weight-bearing range-of-motion.
Measured: at least 6 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 posted20 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; ArthroplastyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restor3D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard D Komistek, PhD, Principal investigator, Univeristy of TennesseeHarold Cates, MD, Principal investigator, Tennessee Orthopaedic Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882751
- Sponsor's protocol ID
- Komistek 2
- Status last verified
- Oct 2023
- First submitted
- 21 May 2013
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Determination & Comparison of Knee Kinematics for Subjects Implanted With Either a Personalized ConforMIS or Traditional Knee Implant
- ClinicalTrials.gov ID
- NCT01882751
- Acronym / sponsor ID
- Komistek 2
- Conditions
- Complications; Arthroplasty
- Keywords
- kinematics, knee joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Restor3DIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jul 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 20 Jun 2013 (estimated)
- 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.
A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Previously, most experimental studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested the knee in a weight-bearing mode. Others have used exoskeletal linkages and skin markers that permit error due to undesired motions between markers and the underlying bone. More recently, fluoroscopy has been used to assess in vivo kinematics for subjects having a TKA.
ConforMIS has attempted to follow a clearly different path than the major orthopaedic companies. They have chosen to offer patients a personalized knee implant based off of each patient's femoral and tibial bone geometry. The hypothesis is that these subjects will experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding during weight-bearing knee flexion. Therefore, the objective for this study is to analyze the in vivo kinematics for 25 patients implanted with a personalized ConforMIS TKA and 25 patients implanted with a traditional TKA design to determine if there are any kinematic differences between these TKA designs.
Detailed description
Each subject will be asked to perform five activities in one continuous sequence: (1) stand up from a chair, (2) walk up stairs, (3) walk down stairs, (4) level walking, and (5) a deep knee bend. Subjects will be video recorded from the waist down while performing the activities. The speed level of each trial will be based on the comfort level of the patient. The fluoroscopic images will be stored digitally for subsequent analysis on secure servers and workstations at the University of Tennessee.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ConforMIS | – | Device: Conformis CR Total Knee ReplacementPatients with ConforMIS implants |
| Standard Total Knee Implant | – | Device: Off the ShelfPatients implanted with standard total knee implant |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are at least 6 month post-op with a ConforMIS knee replacement or a standard total knee replacement who meets the inclusion/exclusion criteria
Key inclusion criteria (8 listed)
- At least 6 months post-op
- Between 40-70 years of age
- Body weight of less than 250lbs
- TKA patients will be judged clinically successful with an American Knee Society score of greater than 90
- Must have post-op passive flexion of 100 degrees with no ligamentous laxity or pain
Key exclusion criteria (7 listed)
- Subjects not willing to sign the Informed Consent and HIPAA forms to participate in the study
- BMI >40
- Pregnant females
- Surgical procedures conducted within the past 6 months other than TKA
- Subjects from the physician's list who do not meet study requirements
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 |
|---|---|---|
| Conformis CR Total Knee ReplacementiTotal CR by Conformis | Device | ConforMIS |
| Off the ShelfA standard knee replacement not using ConforMIS' iFit technology | Device | Standard Total Knee Implant |
Primary outcome
Kinematic Patterns during gait
Time frame: at least 6 months post surgery
There are multiple parameters captured by fluoroscopy that will be assessed during these 4 activities including: 1. Anterior/posterior medial and lateral condyle contact positions 2. Axial rotation of the femoral component relative to the tibial component 3. Condylar lift-off will be determined by measuring the distances from the medial and lateral condyles to the polyethylene insert surface 4. Weight-bearing range-of-motion.
Kinematic patterns during deep knee bend
Time frame: at least 6 months post surgery
There are multiple parameters captured by fluoroscopy that will be assessed during these 4 activities including: 1. Anterior/posterior medial and lateral condyle contact positions 2. Axial rotation of the femoral component relative to the tibial component 3. Condylar lift-off will be determined by measuring the distances from the medial and lateral condyles to the polyethylene insert surface 4. Weight-bearing range-of-motion.
Kinematics patterns during going up and down stairs
Time frame: at least 6 months post surgery
There are multiple parameters captured by fluoroscopy that will be assessed during these 4 activities including: 1. Anterior/posterior medial and lateral condyle contact positions 2. Axial rotation of the femoral component relative to the tibial component 3. Condylar lift-off will be determined by measuring the distances from the medial and lateral condyles to the polyethylene insert surface 4. Weight-bearing range-of-motion.
Kinematics patterns during getting up from chair
Time frame: at least 6 months post surgery
There are multiple parameters captured by fluoroscopy that will be assessed during these 4 activities including: 1. Anterior/posterior medial and lateral condyle contact positions 2. Axial rotation of the femoral component relative to the tibial component 3. Condylar lift-off will be determined by measuring the distances from the medial and lateral condyles to the polyethylene insert surface 4. Weight-bearing range-of-motion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Richard D Komistek, PhD principal investigator
Univeristy of Tennessee
Harold Cates, MD principal investigator
Tennessee Orthopaedic Clinics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complications; Arthroplasty, run by Restor3D at 2 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 8 inclusion and 7 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 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Kinematic Patterns during gait (time frame: at least 6 months post surgery). The study lists 4 primary outcomes in all. 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 Oct 2023.