NCT05181566

Brief Summary

After total hip arthroplasty using an 'Modular Dual Mobility' acetabular cup, which is effective in reducing the risk of dislocation, one of the serious complications occurring after total hip arthroplasty, the blood metal ion concentration was compared with that of conventional total hip arthroplasty patients. This is a multicenter prospective randomized comparative study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 5, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 6, 2022

Status Verified

March 1, 2021

Enrollment Period

1.9 years

First QC Date

December 3, 2021

Last Update Submit

December 20, 2021

Conditions

Femur Neck FractureArthroplasty Complications

Keywords

Total hip arthroplastyMetal ionDual mobilityTotal hip replacement

Outcome Measures

Primary Outcomes (1)

  • Change in Metal ion level

    Measurement of metal ion concentration in blood serum

    Baseline (pre op.), post op. 12 months

Secondary Outcomes (12)

  • Change in Clinical measurement (Pain-visual analog scale)

    Post op. 6 months, post op. 12 months, post op. 24 months

  • Change in Clinical measurement (Harris hip score)

    Post op. 6 months, post op. 12 months, post op. 24 months

  • Change in Clinical measurement (Oxford hip score)

    Post op. 6 months, post op. 12 months, post op. 24 months

  • Change in Clinical measurement (UCLA score)

    Post op. 6 months, post op. 12 months, post op. 24 months

  • Change in Radiological measurement (Hip x-ray)

    Baseline (immediate post op.), post op. 6 months, post op. 12 months, post op. 24 months

  • +7 more secondary outcomes

Study Arms (2)

Modular dual mobility group

EXPERIMENTAL

A group of patients who underwent total hip replacement arthroplasty using a modular dual mobility cup

Procedure: Total hip replacement arthroplasty using modular dual mobility cup

Conventional group

ACTIVE COMPARATOR

A group of patients who underwent total hip replacement arthroplasty using a conventional acetabular cup

Procedure: Total hip replacement arthroplasty using conventional acetabular cup

Interventions

Total hip replacement arthroplasty using modular dual mobility cupPROCEDURE

In a total hip replacement (also called total hip arthroplasty), the damaged bone and cartilage is removed and replaced with prosthetic components

Modular dual mobility group
Total hip replacement arthroplasty using conventional acetabular cupPROCEDURE

In a total hip replacement (also called total hip arthroplasty), the damaged bone and cartilage is removed and replaced with prosthetic components

Conventional group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 60 years of age. Femoral neck fracture or hip joint disease. Garden stage III, IV
  • Comorbidities: American Society of Anesthesiology (ASA) grade III or less, Charlson comorbidity 6 points or less
  • Daily activity: UCLA score 4 or higher, Koval score 4 or lower
  • Including patients with neuromuscular disorder and cognitive impairment

You may not qualify if:

  • Revision arthroplasty
  • In case of factors other than fretting corrosion of the index arthroplasty that can cause an increase in serum metal ion level - In case of undergoing surgery using metal on other joints before this operation, vitamin B user
  • Patients with abnormal kidney function in which Blood urea nitrogen (BUN) and Cr are out of normal values
  • Pathologic fracture
  • If you have metabolic bone disorder, exclude osteoporosis (ex. Paraneoplastic syndrome, renal osteodystrophy, Vit D disorder, hormonal disorder)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KoreaUGuroH

Seoul, 08308, South Korea

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Sangmin Kim, Ph.D

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2021

First Posted

January 6, 2022

Study Start

September 5, 2019

Primary Completion

August 3, 2021

Study Completion

December 31, 2025

Last Updated

January 6, 2022

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)