Squeaking in Ceramic-on-Ceramic Total Hip Arthroplasty Us... | NCT04594564

Studies
Squeaking in Ceramic-on-Ceramic Total Hip Arthroplasty Using Delta TT Cup

NCT04594564

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jun 10, 2025Actual

Enrollment

270Actual

Phase

Not provided

Conditions

Osteoarthritis, Hip
Osteonecrosis of Femoral Head
Femoral Neck Fractures
Rheumatoid Arthritis of Hip
Posttraumatic Arthropathy

Interventions

Total hip arthroplasty with Delta TT cup

Countries

South Korea

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

May 2025

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

Oct 1, 2020Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

Oct 13, 2020

First Submission Date that Met QC Criteria

Oct 13, 2020

First Posted Date

Oct 20, 2020Actual

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

Jun 5, 2025

Last Update Posted Date

Jun 10, 2025Actual

Name	Class
LIMA Korea	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Description Module

Brief Summary

This study will evaluate clinical outcome on patients who undergo ceramic on ceramic (CoC) bearing total hip arthroplasty (THA) using Delta TT cup.

Detailed Description

This study will evaluate clinical outcome on patients who undergo ceramic on ceramic (CoC) bearing total hip arthroplasty (THA) using Delta TT cup. Specifically the study intends to address the following research topics:

The incidence of squeaking after CoC THA using Delta TT cup.
The dislocation rate and survival rate of CoC THA using Delta TT cup.

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

270Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Total hip arthroplasty with Delta TT cup	Procedure	Total hip arthroplasty using Delta TT cup and ceramic bearings

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Squeaking	Rate of any noise after THA	6 weeks
Squeaking	Rate of any noise after THA	3 months
Squeaking	Rate of any noise after THA	6 months
Squeaking	Rate of any noise after THA	9 months
Squeaking	Rate of any noise after THA	12 months
Squeaking	Rate of any noise after THA	24 months

Secondary Outcomes

Measure	Description	Time Frame
Dislocation	Dislocation rate after THA	6 weeks
Dislocation	Dislocation rate after THA	3 months

Other Outcomes

Measure	Description	Time Frame
Range of motion	Change of range of motion after THA	24 months
Survivorship of implant	Survival rate of prosthesis	24 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Older than 18 years old
Non-inflammatory degenerative joint disease such as osteoarthritis or avascular necrosis
Rheumatoid arthritis
Post-traumatic arthritis
Fractures of femoral neck

Exclusion Criteria:

Local or systemic infection
Septicaemia
Persistent acute or chronic osteomyelitis
Confirmed nerve or muscle lesion compromising hip joint function
Unstable medical illness
Rapidly progressive neurological disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Those who undergo THA for their advanced hip disease.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Young-Kyun Lee	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	13620	South Korea

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
D015207	Osteoarthritis, Hip
D005271	Femur Head Necrosis
D005265	Femoral Neck Fractures
D004204	Joint Dislocations

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019644	Arthroplasty, Replacement, Hip

Ancestor Terms

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided