A Post-Market Retrospective Study on Revision Total Knee... | NCT02912351

Studies
A Post-Market Retrospective Study on Revision Total Knee Arthroplasty Using Medacta GMK® Revision Prosthesis

NCT02912351

Sponsor

Medacta USA

Status

Completed

Last Update Posted

Apr 1, 2022Actual

Enrollment

24Actual

Phase

Not provided

Conditions

Osteoarthritis

Interventions

Patient record review, Radiographs, and questionaires.

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

Mar 2022

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

Jan 2017

Primary Completion Date

Mar 2022Actual

Completion Date

Mar 2022Actual

First Submitted Date

Jan 4, 2016

First Submission Date that Met QC Criteria

Sep 20, 2016

First Posted Date

Sep 23, 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 30, 2022

Last Update Posted Date

Apr 1, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 is a retrospective, single-site observational study, designed to assess the clinical outcomes and collect safety data of GMK Revision knee system used for primary or revision total knee arthroplasty at minimum two years post-treatment.

Detailed Description

Not provided

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

24Actual

Name	Type	Description	Arm Group Labels	Other Names
Patient record review, Radiographs, and questionaires.	Other	KSS-Objective Knee Scores, KSS Subsets, Radiographs and Patient Satisfaction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Knee Society Scores (KSS)	Total Knee Society Score questionnaire to assess Patient satisfaction and Patient expectations and objective knee scores.	Minimum 2 years post surgery

Secondary Outcomes

Measure	Description	Time Frame
Radiographic Analysis	Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration and the presence and progression of radiolucent line between the prosthesis, bone and cement.	Minimum 2 years post surgery
Patient Satisfaction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to any study procedure.
Patients with ability to understand and provide written authorization for use and disclosure of personal health information
Patients must be willing to comply with the post-operative evaluation schedule.
Patients underwent either a primary or revision total knee replacement for any type of etiology (Osteoarthritis, Avascular necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis, Polyarthritis, Primary implantation failure).
Patients must have received a GMK Revision component
Patients must be at minimum 2 year (24 months) post-treatment
The operation was performed or supervised by the investigator.
No age limit criteria

Exclusion Criteria:

History of alcoholism
Currently on chemotherapy or radiation therapy
Habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than knee pain
History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
History of chronic pain issues for reasons other than knee pain
Women that are pregnant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

For patients that had received the treatment modality, GMK Revision Knee System and are at least 2 years (24 months) out from surgery.

Sampling Method

Probability Sample

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

ID	Term
D060733	Electromagnetic Radiation
D055590	Electromagnetic Phenomena
D060328	Magnetic Phenomena
D055585	Physical Phenomena