KineSpring® System Patient Preference Study | NCT02934672

Studies
KineSpring® System Patient Preference Study

NCT02934672

Sponsor

Moximed

Status

Completed

Last Update Posted

Mar 11, 2019Actual

Enrollment

323Actual

Phase

Not provided

Conditions

Osteoarthritis of the Knee

Interventions

Survey

Countries

Not provided

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

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Oct 13, 2016

First Submission Date that Met QC Criteria

Oct 13, 2016

First Posted Date

Oct 17, 2016Estimated

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

Mar 7, 2019

Last Update Posted Date

Mar 11, 2019Actual

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 primary objectives of the survey are to obtain patient preference information that can be useful during the benefit-risk assessment of the KineSpring System.

Detailed Description

Well-established, quantitative research methods were employed to understand the relative importance of effectiveness, safety, and other characteristics of orthopedic surgical treatments and develop a benefit-risk model to inform regulatory decision making.

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

323Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Survey	Other	Internet panelists, who self-reported that they or another adult in their household has osteoarthritis, were sent an email invitation to the survey site.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient preferences for knee osteoarthritis surgical procedures	Patient preference for knee osteoarthritis surgeries	At time of survey

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females aged 25 - 80 years
Diagnosed with osteoarthritis in the knee
Experience pain in the knee of greater than or equal to a "4" on a "0 - 10" scale, where 0 means not at all painful and 10 means extremely painful
Experience knee pain at least once a week
Previously failed non-surgical treatments for knee OA pain
Pass a security screen

Exclusion Criteria:

Do not suffer or has not been diagnosed with knee osteoarthritis
Has had knee surgical intervention involving an implant or a prosthesis (i.e. total knee replacement, unicompartmental knee arthroplasty, high tibial osteotomy)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Males and females aged 25 to 80 years old diagnosed with osteoarthritis in the knee

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Tessa Yamut	Moximed	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28974919	Result	Moorman CT 3rd, Kirwan T, Share J, Vannabouathong C. Patient Preferences Regarding Surgical Interventions for Knee Osteoarthritis. Clin Med Insights Arthritis Musculoskelet Disord. 2017 Sep 20;10:1179544117732039. doi: 10.1177/1179544117732039. eCollection 2017.

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

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms