NCT04594564

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 10, 2025

Status Verified

May 1, 2025

Enrollment Period

3.2 years

First QC Date

October 13, 2020

Last Update Submit

June 5, 2025

Conditions

Osteoarthritis, HipOsteonecrosis of Femoral HeadFemoral Neck FracturesRheumatoid Arthritis of HipPosttraumatic Arthropathy

Keywords

Total hip arhtroplastySqueakingDislocationCeramic bearings

Outcome Measures

Primary Outcomes (6)

  • 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 (6)

  • Dislocation

    6 weeks

  • Dislocation

    3 months

  • Dislocation

    6 months

  • Dislocation

    9 months

  • Dislocation

    12 months

  • +1 more secondary outcomes

Other Outcomes (2)

  • Range of motion

    24 months

  • Survivorship of implant

    24 months

Interventions

Total hip arthroplasty with Delta TT cupPROCEDURE

Total hip arthroplasty using Delta TT cup and ceramic bearings

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those who undergo THA for their advanced hip disease.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, HipFemur Head NecrosisFemoral Neck FracturesJoint Dislocations

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOsteonecrosisBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsHip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Young-Kyun Lee

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 20, 2020

Study Start

October 1, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

June 10, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)