Survivorship and Outcomes of Robotic-Arm Assisted Medial... | NCT03668717

Studies
Survivorship and Outcomes of Robotic-Arm Assisted Medial Unicompartmental Knee Arthroplasty

NCT03668717

Sponsor

St. Helena Hospital Coon Joint Replacement Institute

Status

Unknown status

Last Update Posted

Sep 13, 2018Actual

Enrollment

133Actual

Phase

Not provided

Conditions

Osteoarthritis

Interventions

Robotic-arm assisted medical MCK implant

Countries

United States

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

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Apr 2026Estimated

Completion Date

Apr 2026Estimated

First Submitted Date

Sep 28, 2016

First Submission Date that Met QC Criteria

Sep 10, 2018

First Posted Date

Sep 13, 2018Actual

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

Sep 10, 2018

Last Update Posted Date

Sep 13, 2018Actual

Name	Class
Stryker Orthopaedics	INDUSTRY

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

The purpose of the study is to determine the survivorship of robotic-arm assisted MCK medial onlay Unicompartmental knee arthroplasty implants at two, five and tem year follow up.

Detailed Description

The purpose of the study is to determine the survivorship of robotic-arm assisted MCK medial onlay unicompartmental knee arthroplasty implants at two, five, and ten year follow up. Study participants will also be asked about their level of satisfaction with their knee function following their robotic-arm assisted Unicompartmental Arthroplasty.

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

133Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Robotic-arm assisted medical MCK implant	Device	Robotic-arm assisted medical MCK implant system to replace the medial compartment of the knee.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
% of patients with revisions	To determine the revision rate in this patient population	10 year after surgery

Secondary Outcomes

Measure	Description	Time Frame
% of patients with revisions	To determine the revision rate in this patient population	2 years after surgery

Other Outcomes

Measure	Description	Time Frame
% of patients with revisions	To determine the revision rate in this patient popluation	5 years after surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients over 21 years of age who underwent primary robotic-arm assisted unicompartmental arthroplasty and received a medial MCK onlay implant and are at least 24 months post-operative.
Patient has signed an IRB approved Informed Consent Form or with IRB approved waiver of written consent, patient has verbally consented to study participations.
Patient willing to comply with follow up.

Exclusion Criteria:

Patient will be excluded from participation in the study if they are cognitively unable to answer questions related to their index procedure and health related quality of life forms.
Patient had active infection
Medial MCK onlay implants were implanted without bone cement
Patients did not have sufficient bone stock to allow for insertion and fixation of components
Patient did not have sufficient soft tissue integrity to allow for stability
Patient had a neurological or muscular deformity that did not allow for control of the knee.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients over 21 years of age who required a primary robotic-arm assisted medial unicompartmental arthroplasty.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Coon, MD	St. Helena Hospital Coon Joint Replacement Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Helena Hospital Coon Joint Replacement Institute		St. Helena	California	94574	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided