Multi-Center Study to Evaluate the ConforMIS iUni Knee Implant

An observational study of Osteoarthritis, run by Restor3D at 8 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

Study is prospective and multi-center. Study will include 100 to 200 patients across up to 20 sites.The study sites will be located in the United States.The study objective is to evaluate the safety and performance of the ConforMIS iUni® Unicompartmental Knee Resurfacing Device in patients with single compartment… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoarthritis
What is being tested?: iUni® Unicompartmental Knee Resurfacing Device
Type of treatment: Medical device
How many people: 120 participants
Where: 8 sitesUnited States
Study dates: Apr 2010to 10 Jan 2023
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 over 18 who have uni-compartmental osteoarthritis to be treated with a unilateral knee resurfacing procedure

Who may be able to join

Clinical condition included in the approved Indications For Use
Unicompartmental osteoarthritis of the medial or lateral tibiofemoral compartment
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 > 35
Treatment for cancer within the past 5 years, with the exception of skin cancer
Poorly controlled diabetes
Neuromuscular conditions which prevent patient from participating in study activities
Active local or systemic infection

Show all 19Show fewer

Immunocompromised
Fibromyalgia or other general body pain related condition
Advanced tricompartmental osteoarthritis
Symptomatic patellofemoral disease
Rheumatoid arthritis or other forms of inflammatory joint disease
Loss of bone or musculature, osteoporosis, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified
Advanced loss of osteochondral structure on the affected femoral condyle
Compromised ACL, PCL or collateral ligament
Severe (>15º) fixed valgus or varus deformity
Extension deficit > 15 º
Prior history of failed implant surgery of the joint to be treated
Unwilling or unable to comply with study requirements
Participation in another clinical study which would confound results

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

JFK Medical Center
Atlantis, Florida, 33462
Great Lakes Bone and Joint
Battle Creek, Michigan, 49015
Advanced Orthopedics and Sports Medicine
Cypress, Texas, 77429
Heekin Clinic
Jacksonville, Florida, 32204
S.T.A.R. Orthopaedics
La Quinta, California, 92253
Arkansas Specialty Orthopaedics & HipKneeArkansas Foundation for the Facility
Little Rock, Arkansas, 72205
Orthopedic Associates of Pittsburgh
Monroeville, Pennsylvania, 15146
Center for the Knee and Shoulder
Monterey, California, 93940

Other trials in United States

About this study

Official title: A Prospective, Multi-Center Study to Evaluate the ConforMIS iUni® G2 Unicompartmental Knee Resurfacing Device

Read the detailed description

The iUni G2 Unicompartmental Resurfacing Device (iUni) is an FDA cleared and CE Marked implant designed for patients with damage isolated to either the medial or lateral tibiofemoral compartment of the knee. The study subjects will be followed for 10 years post implant. The study objective is to evaluate the safety and performance of the ConforMIS iUni® Unicompartmental Knee Resurfacing Device in patients with single compartment osteoarthritis. The iUni is a patient-specific unicompartmental resurfacing device designed from the patient's unique anatomy using proprietary software which interprets data from the patient's CT scan. The patient matched implant design is then coupled with unique patient-matched disposable instrumentation designed using the same CT data and software. The follow-up visit schedule will include visits at 6 weeks, 6 months (optional), 1 year, 2 years, 5 years and 10 years post implant.The remaining follow-up data collected at years 3, 4, 6, 7, 8, and 9 may be collected via phone call/email and does not require a subject visit to the site.The study sites will be located in the United States.

Conditions: Osteoarthritis
Being tested: iUni® Unicompartmental Knee Resurfacing Device
Keywords: knee, osteoarthritis, unicompartmental, arthroplasty, knee resurfacing, Conformis, patient specific
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

iUni® Unicompartmental Knee Resurfacing DeviceDevice
The iUni® Unicompartmental Resurfacing Device is an FDA cleared and CE Marked implant designed for patients with damage isolated to either the medial or lateral tibiofemoral compartment of the knee. The patient-specific iUni is designed from a CT scan of an individual patient's knee using a design process which interactively maps the diseased area and defines the extent of misalignment present in the knee. This process allows definition of the shape and size of the femoral and tibial components of the implant, as well as the disposable instrumentation

Study groups in NCT01117571
Study group	Role	What they receive
open label		iUni® Unicompartmental Knee Resurfacing Device Receives: Device: iUni® Unicompartmental Knee Resurfacing Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Knee Society Score
to assess knee pain and function
Measured: 2 years
WOMAC Osteoarthritis Index
to assess knee pain and function
Measured: 2 years

Secondary outcomes (5)

Knee Society Score and WOMAC at years 5 and 10 post-implantation
Patient reported outcomes measuring pain and function
Measured: 10 years
Annual revision rates at years 1 through 10 post-implantation
Number of revision rates
Measured: 10 years
Incidence of major procedure-related and device-related complications
rate of incidence of serious adverse events that are related to the device or the procedure
Measured: 10 years
Length of tourniquet time in minutes
how long the tourniquet was on the patient in surgery
Measured: 6 weeks
Length of hospital stay in hours
How long each patient was in the hospitals from admission to discharge
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201010 Jan 2023

First posted5 May 2010 (estimated)
Study startApr 2010
Primary completion30 Oct 2014
Study completion10 Jan 2023

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.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01117571
Sponsor's protocol ID: 09-001
Acronym: iUni
Status last verified: Oct 2023
First submitted: 4 May 2010
Last updated: 25 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis trials

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, Multi-Center Study to Evaluate the ConforMIS iUni® G2 Unicompartmental Knee Resurfacing Device
ClinicalTrials.gov ID: NCT01117571
Acronym / sponsor ID: iUni / 09-001
Conditions: Osteoarthritis
Keywords: knee, osteoarthritis, unicompartmental, arthroplasty, knee resurfacing, Conformis, patient specific
Study type: Observational
Recruitment status: TerminatedReason stopped: Decision of investigational team
Enrolment: 120 participants (actual)
Lead sponsor: Restor3DIndustry (pharma, biotech, devices)
Study start: Apr 2010 (actual)
Primary completion: 30 Oct 2014 (actual)
Study completion: 10 Jan 2023 (actual)
First posted: 5 May 2010 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
open label	–	Device: iUni® Unicompartmental Knee Resurfacing DeviceiUni® Unicompartmental Knee Resurfacing Device

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients over 18 who have uni-compartmental osteoarthritis to be treated with a unilateral knee resurfacing procedure

Key inclusion criteria (4 listed)

Clinical condition included in the approved Indications For Use
Unicompartmental osteoarthritis of the medial or lateral tibiofemoral compartment
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)

Simultaneous bilateral procedure required
BMI > 35
Treatment for cancer within the past 5 years, with the exception of skin cancer
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
iUni® Unicompartmental Knee Resurfacing DeviceThe iUni® Unicompartmental Resurfacing Device is an FDA cleared and CE Marked implant designed for patients with damage isolated to either the medial or lateral tibiofemoral compartment of the knee. The patient-specific iUni is designed from a CT scan of an individual patient's knee using a design process which interactively maps the diseased area and defines the extent of misalignment present in the knee. This process allows definition of the shape and size of the femoral and tibial components of the implant, as well as the disposable instrumentation	Device	open label

Primary outcome

Knee Society Score
Time frame: 2 years
to assess knee pain and function
WOMAC Osteoarthritis Index
Time frame: 2 years
to assess knee pain and function

5 secondary outcomes

Knee Society Score and WOMAC at years 5 and 10 post-implantation
Time frame: 10 years
Annual revision rates at years 1 through 10 post-implantation
Time frame: 10 years
Incidence of major procedure-related and device-related complications
Time frame: 10 years
Length of tourniquet time in minutes
Time frame: 6 weeks
Length of hospital stay in hours
Time frame: 6 weeks

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.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis

Recruiting
Oral Nutritional Optimization in Total Joint Arthroplasty
Osteoarthritis
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Facet Joint Arthropathy, Pain
Recruiting
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Ankle Osteoarthritis, Foot Osteoarthritis

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.

C. Lowry Barnes, M.D principal investigator

Hip Knee Arkansas Foundation

Marc Quartulli study director

Restor3D

8 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, 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 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 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?

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?

Knee Society Score (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT01117571.

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; AzTrials last refreshed its copy on 31 Oct 2026.