NCT05547984

Brief Summary

A randomized controlled trial comparing modular dual mobility inserts with ceramic multilayer coating versus standard polyethylene inserts for primary THA in a cementless acetabular cup

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
27mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress61%
Nov 2022Aug 2028

First Submitted

Initial submission to the registry

September 16, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 21, 2022

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

4.8 years

First QC Date

September 16, 2022

Last Update Submit

December 15, 2025

Conditions

Coxarthrosis; Primary

Keywords

Dual Mobility CupTotal Hip Arthroplasty

Outcome Measures

Primary Outcomes (2)

  • Serum metal ion analysis (Cobalt)

    Cobalt ion levels in blood serum in measured in \[µg/L\], Comparison between the two groups

    12 months after surgery

  • Serum metal ion analysis (Chromium)

    Chromium ion levels in blood serum in measured in \[µg/L\], Comparison between the two groups

    12 months after surgery

Secondary Outcomes (7)

  • Change of functional outcome over three year follow-up period (Harris Hip Score)

    3 months, 12 months and 3 years postoperatively

  • Gait analysis over time

    preoperative, 3 months and 12 months postoperatively

  • Development of Patient satisfaction with surgery result over time

    at three examinations during Follow-Up (3 months postop, 1 year postop, 3 years postop)

  • Radiologic Evaluation: Cup Inclination over time

    immediately postoperative, 3 months, 12 months and 3 years postoperative

  • Radiologic Evaluation: center of rotation

    immediately postoperative, 3 months, 12 months and 3 years postoperative

  • +2 more secondary outcomes

Study Arms (2)

Dual Mobility Cup

EXPERIMENTAL

dual mobility articulation

Device: Dual Mobility Cup

Standard Acetabular component

ACTIVE COMPARATOR

standard articulation with polyethylene + vitamin E inlay and metal head

Device: Standard Acetabular component

Interventions

Dual Mobility CupDEVICE

Total hip arthroplasty (THA) is a successful and established therapy for coxarthrosis, rheumatic arthritis, hip fractures and femoral head necrosis. The acetabular implant for this arm is the Dual Mobility cup

Also known as: Total Hip Arthroplasty
Dual Mobility Cup
Standard Acetabular componentDEVICE

Total hip arthroplasty (THA) is a successful and established therapy for coxarthrosis, rheumatic arthritis, hip fractures and femoral head necrosis. The acetabular implant for this arm is the standard device with polyethylene + vitamin E inlay and metal head

Also known as: Total Hip Arthroplasty
Standard Acetabular component

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary coxarthrosis patients indicated for cementless total hip arthroplasty
  • Written informed patient consent

You may not qualify if:

  • Hip trauma or revision surgery
  • Rheumatoid or neurologic disease
  • BMI \>35
  • Ongoing oncologic therapy
  • Preoperatively elevated Co or Cr serum levels \>1.0 µg/L
  • Patients with other joint implants, or anticipated need for another joint replacement surgery within the study period
  • Acetabular cup size \<52 expected
  • Patients not able to mentally or physically comply with the study demands and follow-up visits
  • Patients \<18 years at surgery
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masaryk Hospital

Ústí nad Labem, Czechia

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Central Study Contacts

Lutz Dreyer, Dr.

CONTACT

+49746195info@aesculap.de

Stefan Maenz, Dr.

CONTACT

+49746195info@aesculap.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 21, 2022

Study Start

November 21, 2022

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

August 1, 2028

Last Updated

December 16, 2025

Record last verified: 2025-12

Locations

CZ(1)