iUni G2+ Prospective Study | NCT01820676

Studies
iUni G2+ Prospective Study

NCT01820676

Sponsor

Restor3D

Status

Terminated

Last Update Posted

Oct 25, 2023Actual

Enrollment

28Actual

Phase

Not provided

Conditions

Knee Osteoarthritis

Interventions

iUni G2+

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Decision of investigational team

Expanded Access Info

Start Date

Jul 15, 2013Actual

Primary Completion Date

Jul 1, 2017Actual

Completion Date

Oct 14, 2022Actual

First Submitted Date

Mar 26, 2013

First Submission Date that Met QC Criteria

Mar 26, 2013

First Posted Date

Mar 29, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2023

Last Update Posted Date

Oct 25, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is designed to monitor long term clinical outcomes of the iUni G2+ unicompartmental knee replacement

Detailed Description

The study subjects will be followed for 10 years post implant. The follow-up visit schedule will include visits at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post implant.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
iUni G2+		iUni G2+ in all patients	Device: iUni G2+

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iUni G2+	Device	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 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 (Fitz).

Measure	Description	Time Frame
2011 Knee Society Score		1 Year
KOOS Score		1 Year
Oxford Knee Score		1 Year

Eligibility Module

Eligibility 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
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
Immunocompromised
Fibromyalgia or other general body pain related condition
Advanced tricompartmental osteoarthritis
Symptomatic patellofemoral disease
Rheumatoid arthritis or other forms of inflammatory joint disease (excluding Gout unless it is in the treated knee or limiting overall function)
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. Osteoporosis is defined by more than -2.5 standard deviations from the T score as measured on a Dual Energy X-Ray Absortiometry Scan (DEXA) within 2 years of surgery.
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with knee osteoarthritis

Sampling Method

Non-Probability Sample

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases