iUni Foundation Study
This study is ongoing, but not recruiting participants.
Sponsor:
ConforMIS, Inc.
Information provided by (Responsible Party):
ConforMIS, Inc.
ClinicalTrials.gov Identifier:
NCT01117571
First received: May 4, 2010
Last updated: December 4, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Device: iUni® Unicompartmental Knee Resurfacing Device |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Multi-Center Study to Evaluate the ConforMIS iUni® G2 Unicompartmental Knee Resurfacing Device |
Resource links provided by NLM:
Further study details as provided by ConforMIS, Inc.:
Primary Outcome Measures:
- Knee Society Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]to assess knee pain and function
- WOMAC [ Time Frame: 2 years ] [ Designated as safety issue: No ]to assess knee pain and function
- SF-12v2 HEALTH SURVEY [ Time Frame: 2 years ] [ Designated as safety issue: No ]to assess overall pain and function during activities of daily living
Secondary Outcome Measures:
- Pain and function at years 5 and 10 post-implantation [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Annual revision rates at years 1 through 10 post-implantation [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
- Incidence of major procedure-related and device-related complications [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
- Post-operative limb alignment [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Radiographic implant position [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Length of tourniquet time in minutes [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Length of hospital stay in hours [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Additional health economics data [ Time Frame: 10 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | December 2020 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| open label |
Device: iUni® Unicompartmental Knee Resurfacing Device
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Simultaneous bilateral procedure required
- BMI > 35
- History of cancer, other than skin cancer
- Poorly controlled diabetes
- Neuromuscular conditions which prevent patient from participating in study activities
- Active local or systemic infection
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01117571
Locations
| United States, Arkansas | |
| Arkansas Specialty Orthopaedics & HipKneeArkansas Foundation for the Facility | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| S.T.A.R. Orthopaedics | |
| La Quinta, California, United States, 92253 | |
| Center for the Knee and Shoulder | |
| Monterey, California, United States, 93940 | |
| United States, Florida | |
| Heekin Orthopedic Specialists | |
| Jacksonville, Florida, United States, 32204 | |
| Andrews-Paulos Research & Education Institute | |
| Pensacola, Florida, United States, 32561 | |
| United States, Michigan | |
| Great Lakes Bone and Joint | |
| Battle Creek, Michigan, United States, 49015 | |
| United States, Pennsylvania | |
| Orthopedic Associates of Pittsburgh | |
| Monroeville, Pennsylvania, United States, 15146 | |
| United States, Texas | |
| Advanced Orthopedics and Sports Medicine | |
| Cypress, Texas, United States, 77429 | |
Sponsors and Collaborators
ConforMIS, Inc.
More Information
No publications provided
| Responsible Party: | ConforMIS, Inc. |
| ClinicalTrials.gov Identifier: | NCT01117571 History of Changes |
| Other Study ID Numbers: | CCP 09-001 |
| Study First Received: | May 4, 2010 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Food and Drug Administration Germany: BfArM |
Keywords provided by ConforMIS, Inc.:
|
knee osteoarthritis unicompartmental arthroplasty |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013