Osteoarthritis, KneeNCT03152162
A Prospective Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System
An observational study of Osteoarthritis, Knee, run by Restor3D at 4 sites in United States.
Trial summary
This is a prospective clinical study designed to observe the long-term clinical outcomes of total knee arthroplasty using a patient-specific, posterior stabilized implant in patients with osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- iTotal PS KRS
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 May 2017to 1 Nov 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with osteoarthritis of the knee
Who may be able to join
- Clinical condition included in the approved Indications For Use for the iTotal® PS
- Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment.
- Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits
- > 18 years of age
Who cannot join
- Simultaneous bilateral procedure required
- BMI > 40
- Active malignancy (defined as a history of any invasive malignancy - except non- melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
- Poorly controlled diabetes
- Neuromuscular conditions which prevent patient from participating in study activities
- Active local or systemic infection
Show all 17Show fewer
- Immunocompromised
- Fibromyalgia or other general body pain related condition
- Rheumatoid arthritis or other forms of inflammatory joint disease
- Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated on, to an extent that the procedure is unjustified
- Diagnosed with or receiving treatment for Osteoporosis
- Other physical disability affecting the hips, spine, or contralateral knee
- Severe instability due to advanced loss of osteochondral structure
- Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO)
- Unwilling or unable to comply with study requirements
- Participation in another clinical study which would confound results
- Allergy to any of the implant materials
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Texas Institute for Hip & Knee Surgery
Austin, Texas, 78751
UNC Orthopedics
Chapel Hill, North Carolina, 27599
Scott Orthopedic
Huntington, West Virginia, 25702
Mansfield Orthopaedics
Morrisville, Vermont, 05661
About this study
This is a prospective clinical study designed to observe the long-term clinical outcomes of total knee arthroplasty using a patient-specific, posterior stabilized implant in patients with osteoarthritis.
Read the detailed description
The study is prospective. Subjects will be implanted with an iTotal® PS Knee Replacement System. The study will include a minimum of 100 subjects across up to 10 sites. The patients enrolled in this study may represent the first cases of the iTotal PS KRS implanted at a particular site; data collected for the first 15 patients at each site will be analyzed separately from the rest of the enrolled population. This will provide visibility towards determining if there exists a learning curve in the implantation process of the iTotal PS KRS. The study sites will be located in the United States.
- Conditions
- Osteoarthritis, Knee
- Being tested
- iTotal PS KRS
- Keywords
- osteoarthritis, patient-specific, knee replacement, TKA, knee arthroplasty, total knee replacement, posterior stabilized
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTotal PS KRSDevice
Also called ConforMIS iTotal PS
Total knee arthroplasty for treatment of osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Baseline from 1-Year in KSS
Change in Knee Society Scores from the pre-operative visit to the 1-year post-operative visit. The Knee Society Score (KSS) includes an Objective Knee Score, Function Score, Satisfaction Score, and Expectation Score. The objective knee score, completed by the surgeon, includes a VAS score of pain walking on level ground and on stairs or inclines, as well as an assessment of alignment, ligament stability, and ROM, along with deductions for flexion contracture or extensor lag. Patients then record their satisfaction, functional activities, and expectations (Scuderi et al., 2012).
Measured: 2 Years
Secondary outcomes (6)
Change from baseline in KSS at years 2, 5 and 10 post-implantation
The Knee Society Score includes an Objective Knee Score, Function Score, Satisfaction Score, and Expectation Score. The Knee Society Score (KSS) includes an Objective Knee Score, Function Score, Satisfaction Score, and Expectation Score. The objective knee score, completed by the surgeon, includes a VAS score of pain walking on level ground and on stairs or inclines, as well as an assessment of alignment, ligament stability, and ROM, along with deductions for flexion contracture or extensor lag. Patients then record their satisfaction, functional activities, and expectations (Scuderi et al., 2012).
Measured: Up to 10 years
Change from baseline in KOOS at years 1, 2, 5 and 10 post-implantation
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42 question knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems.
Measured: Up to 10 years
Post-operative limb alignment if long leg x-rays available
Comparison of limb alignment between pre-operative and post-operative x-rays.
Measured: 2 years
Length of hospital stay in hours
How long the patient is in the hospital from the time of admission to the time of discharge.
Measured: 1 year
Blood loss during surgery
Estimated blood loss during surgery (mL)
Measured: 1 year
Transfusion rate
Rate of patients who require blood transfusions during surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start1 May 2017
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Why it stopped: Decision of investigational team
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restor3D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Quartulli, Study director, Restor3D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152162
- Sponsor's protocol ID
- 14-003
- Status last verified
- Oct 2023
- First submitted
- 8 May 2017
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
PubMed 17403800Rougraff BT, Heck DA, Gibson AE. A comparison of tricompartmental and unicompartmental arthroplasty for the treatment of gonarthrosis. Clin Orthop Relat Res. 1991 Dec;(273):157-64.
PubMed 1959265Fitzpatrick C, FitzPatrick D, Lee J, Auger D. Statistical design of unicompartmental tibial implants and comparison with current devices. Knee. 2007 Mar;14(2):138-44. doi: 10.1016/j.knee.2006.11.005. Epub 2006 Dec 22.
PubMed 17188876Fitz W. Unicompartmental knee arthroplasty with use of novel patient-specific resurfacing implants and personalized jigs. J Bone Joint Surg Am. 2009 Feb;91 Suppl 1:69-76. doi: 10.2106/JBJS.H.01448.
PubMed 19182028Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
PubMed 19844772Noble PC, Conditt MA, Cook KF, Mathis KB. The John Insall Award: Patient expectations affect satisfaction with total knee arthroplasty. Clin Orthop Relat Res. 2006 Nov;452:35-43. doi: 10.1097/01.blo.0000238825.63648.1e.
PubMed 16967035Scuderi GR, Bourne RB, Noble PC, Benjamin JB, Lonner JH, Scott WN. The new Knee Society Knee Scoring System. Clin Orthop Relat Res. 2012 Jan;470(1):3-19. doi: 10.1007/s11999-011-2135-0. No abstract available.
PubMed 22045067
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
- A Prospective Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System
- ClinicalTrials.gov ID
- NCT03152162
- Acronym / sponsor ID
- 14-003
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, patient-specific, knee replacement, TKA, knee arthroplasty, total knee replacement, posterior stabilized
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Decision of investigational team
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Restor3DIndustry (pharma, biotech, devices)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 12 May 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.
This is a prospective clinical study designed to observe the long-term clinical outcomes of total knee arthroplasty using a patient-specific, posterior stabilized implant in patients with osteoarthritis.
Detailed description
The study is prospective. Subjects will be implanted with an iTotal® PS Knee Replacement System. The study will include a minimum of 100 subjects across up to 10 sites. The patients enrolled in this study may represent the first cases of the iTotal PS KRS implanted at a particular site; data collected for the first 15 patients at each site will be analyzed separately from the rest of the enrolled population. This will provide visibility towards determining if there exists a learning curve in the implantation process of the iTotal PS KRS. The study sites will be located in the United States.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with osteoarthritis of the knee
Key inclusion criteria (4 listed)
- Clinical condition included in the approved Indications For Use for the iTotal® PS
- Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment.
- Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits
- > 18 years of age
Key exclusion criteria (17 listed)
- Simultaneous bilateral procedure required
- BMI > 40
- Active malignancy (defined as a history of any invasive malignancy - except non- melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
- Poorly controlled diabetes
- Neuromuscular conditions which prevent patient from participating in study activities
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 |
|---|---|---|
| iTotal PS KRSAlso: ConforMIS iTotal PSTotal knee arthroplasty for treatment of osteoarthritis | Device | – |
Primary outcome
Change in Baseline from 1-Year in KSS
Time frame: 2 Years
Change in Knee Society Scores from the pre-operative visit to the 1-year post-operative visit. The Knee Society Score (KSS) includes an Objective Knee Score, Function Score, Satisfaction Score, and Expectation Score. The objective knee score, completed by the surgeon, includes a VAS score of pain walking on level ground and on stairs or inclines, as well as an assessment of alignment, ligament stability, and ROM, along with deductions for flexion contracture or extensor lag. Patients then record their satisfaction, functional activities, and expectations (Scuderi et al., 2012).
6 secondary outcomes
Change from baseline in KSS at years 2, 5 and 10 post-implantation
Time frame: Up to 10 years
Change from baseline in KOOS at years 1, 2, 5 and 10 post-implantation
Time frame: Up to 10 years
Post-operative limb alignment if long leg x-rays available
Time frame: 2 years
Length of hospital stay in hours
Time frame: 1 year
Blood loss during surgery
Time frame: 1 year
Transfusion rate
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Decision of investigational team). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Background: PubMed 17403800Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
- Background: PubMed 1959265Rougraff BT, Heck DA, Gibson AE. A comparison of tricompartmental and unicompartmental arthroplasty for the treatment of gonarthrosis. Clin Orthop Relat Res. 1991 Dec;(273):157-64.
- Background: PubMed 17188876Fitzpatrick C, FitzPatrick D, Lee J, Auger D. Statistical design of unicompartmental tibial implants and comparison with current devices. Knee. 2007 Mar;14(2):138-44. doi: 10.1016/j.knee.2006.11.005. Epub 2006 Dec 22.
- Background: PubMed 19182028Fitz W. Unicompartmental knee arthroplasty with use of novel patient-specific resurfacing implants and personalized jigs. J Bone Joint Surg Am. 2009 Feb;91 Suppl 1:69-76. doi: 10.2106/JBJS.H.01448.
- Background: PubMed 19844772Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
- Background: PubMed 16967035Noble PC, Conditt MA, Cook KF, Mathis KB. The John Insall Award: Patient expectations affect satisfaction with total knee arthroplasty. Clin Orthop Relat Res. 2006 Nov;452:35-43. doi: 10.1097/01.blo.0000238825.63648.1e.
- Background: PubMed 22045067Scuderi GR, Bourne RB, Noble PC, Benjamin JB, Lonner JH, Scott WN. The new Knee Society Knee Scoring System. Clin Orthop Relat Res. 2012 Jan;470(1):3-19. doi: 10.1007/s11999-011-2135-0. No abstract available.
- 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.
Marc Quartulli study director
Restor3D
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Restor3D at 4 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 4 inclusion and 17 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 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 4 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 was stopped early (reason given: Decision of investigational team). Results are not available in the source record.
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?
Change in Baseline from 1-Year in KSS (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03152162, which also lists 7 linked publications.
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.