OsteoarthritisLatella-USNCT02608957
Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction
A study testing Latella Knee Implant System in people with Osteoarthritis, run by Cotera, Inc. at 2 sites in United States.
Trial summary
The objective of the Latella-US study is to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis pain. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Latella Knee Implant System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2015to Mar 2017
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of pain due to medial osteoarthritis
- Qualifying baseline pain scores
- Kellgren-Lawrence Grades 2-3
Who cannot join
- Osteoporosis
- Rheumatoid arthritis
- Joint instability
- Metal ion allergy
- Permanent implant in or around the knee joint
- Prior anterior cruciate ligament reconstruction
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rush University Medical Center
Chicago, Illinois, 60612
The George Washington University
Washington D.C., District of Columbia, 20037
About this study
Official title: Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-US Study)
The objective of the Latella-US study is to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis pain.
- Conditions
- Osteoarthritis
- Being tested
- Latella Knee Implant System
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latella Knee Implant SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Latella Knee Implant System | Experimental | Not described Receives: Device: Latella Knee Implant System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint: Mean change in KOOS pain score at 6 months
Mean change in KOOS pain score at 6 months after treatment with the Latella Implant.
Measured: 6 Months
Primary Safety Endpoint: Surgical re-intervention rate at 6 months
Surgical re-intervention rate during the 6 month period following implantation of the Latella device.
Measured: 6 Months
Secondary outcomes (9)
Change in KOOS function score
Measured: 6, 12 and 24 months
Change in medial knee pain NRS (while walking)
Measured: 6, 12 and 24 months
Change in IKDC score
Measured: 6, 12 and 24 months
Device-related complications rate
Measured: 24 months
KOOS responder rate based on OARSI-OMERACT criteria
Measured: 6, 12 and 24 months
Proportion of subjects reaching MCID in KOOS pain score
Measured: 6, 12 and 24 months
Change in KOOS pain score
Measured: 12 and 24 months
Surgical re-intervention rate
Measured: 12 and 24 months
Procedure-related complications rate
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionMay 2016
- Study completionMar 2017
Why it stopped: Sponsor elected to terminate the study prior to subject treatment.
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cotera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608957
- Sponsor's protocol ID
- CIP-0002
- Acronym
- Latella-US
- Status last verified
- Mar 2017
- First submitted
- 13 Nov 2015
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-US Study)
- ClinicalTrials.gov ID
- NCT02608957
- Acronym / sponsor ID
- Latella-US / CIP-0002
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor elected to terminate the study prior to subject treatment.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Cotera, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 20 Nov 2015 (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.
The objective of the Latella-US study is to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Latella Knee Implant System | Experimental | Device: Latella Knee Implant System |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of pain due to medial osteoarthritis
- Qualifying baseline pain scores
- Kellgren-Lawrence Grades 2-3
Key exclusion criteria (6 listed)
- Osteoporosis
- Rheumatoid arthritis
- Joint instability
- Metal ion allergy
- Permanent implant in or around the knee joint
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 |
|---|---|---|
| Latella Knee Implant System | Device | Latella Knee Implant System |
Primary outcome
Primary Efficacy Endpoint: Mean change in KOOS pain score at 6 months
Time frame: 6 Months
Mean change in KOOS pain score at 6 months after treatment with the Latella Implant.
Primary Safety Endpoint: Surgical re-intervention rate at 6 months
Time frame: 6 Months
Surgical re-intervention rate during the 6 month period following implantation of the Latella device.
9 secondary outcomes
Change in KOOS function score
Time frame: 6, 12 and 24 months
Change in medial knee pain NRS (while walking)
Time frame: 6, 12 and 24 months
Change in IKDC score
Time frame: 6, 12 and 24 months
Device-related complications rate
Time frame: 24 months
KOOS responder rate based on OARSI-OMERACT criteria
Time frame: 6, 12 and 24 months
Proportion of subjects reaching MCID in KOOS pain score
Time frame: 6, 12 and 24 months
Change in KOOS pain score
Time frame: 12 and 24 months
Surgical re-intervention rate
Time frame: 12 and 24 months
Procedure-related complications rate
Time frame: 24 Months
Results and safety
The study was stopped early (reason given: Sponsor elected to terminate the study prior to subject treatment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Latella Knee Implant System in people with Osteoarthritis, run by Cotera, Inc. 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 3 inclusion and 6 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 4 Apr 2017. 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 was stopped early (reason given: Sponsor elected to terminate the study prior to subject treatment.). 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?
Primary Efficacy Endpoint: Mean change in KOOS pain score at 6 months (time frame: 6 Months). 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?
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 4 Apr 2017.