The Medacta International SMS Post-Marketing Surveillance... | NCT02748408

Studies
The Medacta International SMS Post-Marketing Surveillance Study

NCT02748408

Sponsor

Medacta International SA

Status

Recruiting

Last Update Posted

Sep 29, 2025Actual

Enrollment

550Estimated

Phase

Not provided

Conditions

Arthrosis
Traumatic Arthritis
Rheumatoid Polyarthritis
Congenital Hip Dysplasia
Avascular Necrosis of the Femoral Head

Interventions

SMS femoral stem

Countries

Austria
Italy
Switzerland
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

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Jul 2032Estimated

Completion Date

Jul 2032Estimated

First Submitted Date

Apr 11, 2016

First Submission Date that Met QC Criteria

Apr 21, 2016

First Posted Date

Apr 22, 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

Sep 23, 2025

Last Update Posted Date

Sep 29, 2025Actual

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

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

550Estimated

Name	Type	Description	Arm Group Labels	Other Names
SMS femoral stem	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
survivorship of the Medacta SMS femoral stem		10-year

Secondary Outcomes

Measure	Description	Time Frame
clinical performance	Harris Hip Score	3, 5, 7 and 10 years
radiographic performance	presence of radiolucencies	3, 5, 7 and 10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals with a severely painful and/or disabling hip joint with osteoarthritis, traumatic arthritis or developmental dysplasia of the hip or avascular necrosis of the femoral head.
In order to take part in this study, all study participants must be between the ages of 18 and 75 years of age, at the time of surgery.
Scheduled for a primary total hip replacement.

Exclusion Criteria:

Active infection
Pregnancy
Mental illness where the known condition is likely to compromise the patient's ability to consent, affect the patient's assessment of their progress or complete the 10 year cycle of follow-up appointments and reviews
Grossly distorted anatomy (surgeon's discretion)
Osteomalacia where uncemented implant fixation is contraindicated
Active rheumatoid arthritis.
Osteoporosis
Metabolic disorders which may impair bone formation where uncemented implant fixation is contraindicated
Muscular atrophy or neuromuscular disease
Allergy to implant material
Any patient who cannot or will not provide informed consent for participation in the study
Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Individuals suitable for hip replacement using the Medacta SMS femoral stem

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
Mara Colombo, Eng	Contact	0041 91 6966060		colombo@medacta.ch

Facility	Status	City	State	ZIP	Country	Contacts
Herz-Jesu Krankenhaus	Recruiting	Vienna		1030	Austria

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
D006618	Hip Dislocation, Congenital
D005271	Femur Head Necrosis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided