The Medacta International GMK Sphere Cementless Post-Mark... | NCT05003414

Studies
The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study

NCT05003414

Sponsor

Medacta International SA

Status

Active, not recruiting

Last Update Posted

Sep 29, 2025Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Arthritis
Traumatic Arthritis
Rheumatoid Arthritis
Poly-arthritis
Avascular Necrosis

Interventions

GMK Sphere cementless Knee Replacement

Countries

France
Switzerland

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

Jun 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2020Actual

Primary Completion Date

Jan 31, 2030Estimated

Completion Date

Dec 31, 2032Estimated

First Submitted Date

Aug 6, 2021

First Submission Date that Met QC Criteria

Aug 6, 2021

First Posted Date

Aug 12, 2021Actual

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 23, 2025

Last Update Posted Date

Sep 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

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

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GMK Sphere cementless Knee Replacement	Device	Performance of Total Knee Arthroplasty (TKA) with GMK Sphere cementless Knee Replacement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival rate	Kaplan Meier method	10 years

Secondary Outcomes

Measure	Description	Time Frame
Clinical outcome: Knee Society score	Knee Society Score (KSS): evaluates pain, in a total of 50 points, stability, 25 points, and range of motion, 25 points. The maximum score of 100 points is reached when there is no pain, with good alignment of the knee in extension, and at least 125° of range of motion, without any anteroposterior or mediolateral instability.	Preop and 1, 2, 5, 10 years postop

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A disabled or severely disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis, poly-arthritis or avascular necrosis
Patients between the age of 18 and 80 at the time of consent
Listed for total knee replacement surgery.
Patients who are willing and able to give informed written consent

Exclusion Criteria:

Progressive local or systemic infection
Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable
Severe instability secondary to advance destruction of condralar structures or loss of integrity of the medial or lateral ligament
Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
Patient whose BMI exceeds 40
Any case not described in the inclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients requiring Total Knee Arthroplasty and who are suitable to receive Medacta GMK Sphere cementless Knee Replacement will be proposed to take part to the current post-market surveillance study during their pre-operative visit.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emmanuel Marchetti, MD	Clinique Saint Vincent de Paul	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Saint Vincent de Paul		Bourgoin		38300	France
Clinique du Parc

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
D001168	Arthritis
D001172	Arthritis, Rheumatoid
D010020	Osteonecrosis

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided