OsteoarthritisNCT02494544
A Multicenter Study to Evaluate Functional Outcome After Knee Replacement
A study testing Off the Shelf Total Knee Replacement and ConforMIS iTotal Knee Replacement in people with Osteoarthritis, run by Restor3D at 8 sites in United States.
Trial summary
Patients will be consecutively enrolled by implant. Implant groups will be those who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system. The patient will conduct functional testing and answer questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Off the Shelf Total Knee Replacement and ConforMIS iTotal Knee Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Jul 2015to 16 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical condition included in the approved Indications For Use for the iTotal CR
- 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
- Subject will require a simultaneous bilateral procedure
- Other lower extremity surgery within 1 year
- Severe (> 15º) fixed valgus or varus deformity
- Severe (> 15º) extension deficit
- Severe instability due to advanced loss of osteochondral structure
- Loss of bone or musculature, osteoporosis, neuromuscular or vascular compromise in the area of the joint to be operated on to an extent that the procedure is unjustified
Show all 19Show fewer
- Insufficient bone stock on the femoral or tibial surfaces
- Contralateral knee replacement surgery within the past 6 months
- 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 (defined as HbA1c >7 or surgeon discretion)
- Immunocompromised
- Other physical disability affecting the hips, spine, or contralateral knee that limits function
- Disabling chronic pain with narcotic dependence
- Compromised PCL or collateral ligament
- Prior history of failed implant surgery of the joint to be treated, including Unicompartmental Knee Arthroplasty (UKA), or Bicompartmental Knee Arthroplasty (BKA)
- Prior history of failed high tibial osteotomy (HTO)
- Participation in another clinical study which would confound results
- Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
OrthoNY
Albany, New York, 12205
Tufts University
Boston, Massachusetts, 02111
The Lindner Center for Research and Education
Cincinnati, Ohio, 45219
University of Missouri
Columbia, Missouri, 65212
University of California in San Diego
La Jolla, California, 92037
Yale School of Medicine
New Haven, Connecticut, 06520
Denver-Vail Orthopedics
Parker, Colorado, 80134
Sharp Healthcare
San Diego, California, 92123
About this study
Official title: A Prospective, Multicenter Study to Evaluate Functional Outcome After Knee Replacement
Patients will be consecutively enrolled by implant. Implant groups will be those who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.
The patient will conduct functional testing and answer questionnaires.
The results will compare the ConforMIS iTotal with an Off the Shelf Knee replacement.
Read the detailed description
To compare functional and patient reported outcome data for a consecutively enrolled group of subjects who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.The person conducting the functional testing will be blinded to the device implanted. Sites will perform the off-the-shelf total knees conventional instrumentation.
- Conditions
- Osteoarthritis
- Being tested
- Off the Shelf Total Knee Replacement, ConforMIS iTotal Knee Replacement
- Keywords
- knee implant, knee replacement, total knee replacement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Off the Shelf Total Knee ReplacementDevice
A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
ConforMIS iTotal Knee ReplacementDevice
A knee replacement performed with patient specific implant and surgical jigs.
| Study group | Role | What they receive |
|---|---|---|
| ConforMIS iTotal Knee replacement | Active comparator | iTotal patient-specific knee replacement system Receives: Device: ConforMIS iTotal Knee Replacement |
| DePuy total knee replacement | Active comparator | Off the shelf knee replacement system Receives: Device: Off the Shelf Total Knee Replacement |
| Zimmer total knee replacement | Active comparator | Off the shelf knee replacement system Receives: Device: Off the Shelf Total Knee Replacement |
| Biomet total knee replacement | Active comparator | Off the shelf knee replacement system Receives: Device: Off the Shelf Total Knee Replacement |
| Smith & Nephew total knee replacement | Active comparator | Off the shelf knee replacement system Receives: Device: Off the Shelf Total Knee Replacement |
| Stryker total knee replacement | Active comparator | Off the shelf knee replacement system Receives: Device: Off the Shelf Total Knee Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure
Comparing the functional testing differences between iTotal and off the shelf. "Total Functional Activities Score" - a subscale within the Knee Society Score (KSS) with its individual subscale score. The Total Functional Activities Score subscale interprets the functional knee health of each patient via a series of tests such as walking/standing (30 points), standard activities (30 points), advanced activities (25 points), and sports/recreational activities (15 points). Deductions to score are made for factors that limit a patient's mobility, such as needing to use an ambulatory device. The subscale scoring system ranges from 0-100, with higher scores indicating better knee function.
Measured: 1 year
Secondary outcomes (2)
Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure
Measuring and comparing the differences between iTotal and off the shelf knees with patient reported outcomes. "Patient Satisfaction", a subscale within the Knee Society Score (KSS), was utilized to capture this metric. The Patient Satisfaction subscale combines scores given for certain responses (very satisfied, satisfied, neutral, somewhat dissatisfied, very dissatisfied) across 5 questions. These questions are designed to determine the level of satisfaction a patient has with their implant across both everyday and active activities. This score ranges from 0-40, with higher scores indicating higher levels of patient satisfaction.
Measured: 1 year
Incidents of Major Procedure-related and Device Related Complications (Including Revision Rates)
All complications were stratified according to clinicaltrials.gov reporting standards and each site labeled each complication as either device-related, non-device-related, procedure-related, and non-procedure-related.
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 posted10 Jul 2015 (estimated)
- Study start1 Jul 2015
- Primary completion16 Nov 2022
- Study completion16 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.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restor3D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary O'Connor, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494544
- Sponsor's protocol ID
- 12-005
- Status last verified
- Nov 2025
- First submitted
- 28 May 2015
- Last updated
- 21 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study to Evaluate Functional Outcome After Knee Replacement
- ClinicalTrials.gov ID
- NCT02494544
- Acronym / sponsor ID
- 12-005
- Conditions
- Osteoarthritis
- Keywords
- knee implant, knee replacement, total knee replacement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision of investigational team
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Restor3DIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Posted 8 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will be consecutively enrolled by implant. Implant groups will be those who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.
The patient will conduct functional testing and answer questionnaires.
The results will compare the ConforMIS iTotal with an Off the Shelf Knee replacement.
Detailed description
To compare functional and patient reported outcome data for a consecutively enrolled group of subjects who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.The person conducting the functional testing will be blinded to the device implanted. Sites will perform the off-the-shelf total knees conventional instrumentation.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ConforMIS iTotal Knee replacement | Active comparator | Device: ConforMIS iTotal Knee ReplacementiTotal patient-specific knee replacement system |
| DePuy total knee replacement | Active comparator | Device: Off the Shelf Total Knee ReplacementOff the shelf knee replacement system |
| Zimmer total knee replacement | Active comparator | Device: Off the Shelf Total Knee ReplacementOff the shelf knee replacement system |
| Biomet total knee replacement | Active comparator | Device: Off the Shelf Total Knee ReplacementOff the shelf knee replacement system |
| Smith & Nephew total knee replacement | Active comparator | Device: Off the Shelf Total Knee ReplacementOff the shelf knee replacement system |
| Stryker total knee replacement | Active comparator | Device: Off the Shelf Total Knee ReplacementOff the shelf knee replacement system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical condition included in the approved Indications For Use for the iTotal CR
- 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 (19 listed)
- Subject will require a simultaneous bilateral procedure
- Other lower extremity surgery within 1 year
- Severe (> 15º) fixed valgus or varus deformity
- Severe (> 15º) extension deficit
- Severe instability due to advanced loss of osteochondral structure
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 |
|---|---|---|
| Off the Shelf Total Knee ReplacementA knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker | Device | Biomet total knee replacement, DePuy total knee replacement, Smith & Nephew total knee replacement, Stryker total knee replacement, Zimmer total knee replacement |
| ConforMIS iTotal Knee ReplacementA knee replacement performed with patient specific implant and surgical jigs. | Device | ConforMIS iTotal Knee replacement |
Primary outcome
Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure
Time frame: 1 year
Comparing the functional testing differences between iTotal and off the shelf. "Total Functional Activities Score" - a subscale within the Knee Society Score (KSS) with its individual subscale score. The Total Functional Activities Score subscale interprets the functional knee health of each patient via a series of tests such as walking/standing (30 points), standard activities (30 points), advanced activities (25 points), and sports/recreational activities (15 points). Deductions to score are made for factors that limit a patient's mobility, such as needing to use an ambulatory device. The subscale scoring system ranges from 0-100, with higher scores indicating better knee function.
2 secondary outcomes
Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure
Time frame: 1 year
Incidents of Major Procedure-related and Device Related Complications (Including Revision Rates)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Mary O'Connor, MD principal investigator
Yale University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Off the Shelf Total Knee Replacement and ConforMIS iTotal Knee Replacement in people with Osteoarthritis, run by Restor3D at 8 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 19 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 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 8 Oct 2025). 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?
Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure (time frame: 1 year). 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 21 Nov 2025.