NCT04375345

Brief Summary

A retrospective study evaluating clinical and radiographic early outcomes of total hip arthroplasty and revision hip arthroplasty with DELTA Multihole TT cup.

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

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

January 23, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2022

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

2 years

First QC Date

April 29, 2020

Last Update Submit

May 4, 2020

Conditions

Hip OsteoarthritisArthroplasty ComplicationsHip Dysplasia

Keywords

total hip arthroplastyhip arthroplasty revisioncomplex primary arthroplastytrabecular titanium

Outcome Measures

Primary Outcomes (1)

  • Percentage of HHS score equal or greater than "Good" at 2 years after surgery

    Month 24

Secondary Outcomes (4)

  • Radiographic implant evaluation and stability assessment

    Week 6, Week 12, Month 6, Month 12, Month 24

  • Survival rate

    Month 24

  • Patients recovery at 2 years after surgery evaluated using the 5-level EQ-5D version (EQ-5D-5L).

    Month 24

  • Incidence of device-related Adverse Events / Serious Adverse Events

    Intraoperative, Week 6, Week 12, Month 6, Month 12, Month 24

Interventions

hip arthroplastyDEVICE

complex primary total hip arthroplasty or revision total hip arthroplasty performed through anterolateral or posterolateral approach

Also known as: revision hip arthroplasty

Eligibility Criteria

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

Study participants will be selected from patients who underwent a Total Hip Arthroplasty with the DELTA Multihole TT cup. Both complex primary and revision cases are considered.

You may qualify if:

  • Age ≥ 18 years
  • Non-inflammatory degenerative joint disease such as osteoarthritis or avascular necrosis;
  • Signed Informed consent
  • Hip dislocation using protruded liners, spacers;
  • Rheumatoid arthritis;
  • Post-traumatic arthritis;
  • Correction of functional deformity in case of acetabulum verticalization, anteversion, and retroversion;
  • Fractures of femoral neck;
  • If used in combination with spacers and hemispheric modules, other indications are:
  • Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure;
  • Clinical management problem where arthrodesis or alternative reconstruction techniques are less likely to achieve satisfactory results;
  • Where bone stock is of poor quality or is inadequate for other reconstruction techniques as indicated by deficiencies of the acetabulum.

You may not qualify if:

  • Local or systemic infections;
  • Septicaemia;
  • Persistent acute or chronic osteomyelitis;
  • Confirmed nerve or muscle lesion compromising hip joint function;
  • Vascular or nerve diseases affecting the concerned limb;
  • Poor bone stock compromising the stability of the implant;
  • Metabolic disorders which may impair fixation and stability of the implant;
  • Any concomitant disease and dependence that might affect the implanted prosthesis;
  • Metal hypersensitivity to implant materials.
  • Female patients who are pregnant, nursing, or planning a pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd University Department of Orthopaedic and Trauma Surgery Comenius University Faculty of Medicine

Bratislava, 85107, Slovakia

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, HipHip Dislocation

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesJoint DislocationsWounds and InjuriesHip Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Boris Steno, MD PhD Prof

    University Hospital Bratislava

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Boris Steno, MD PhD Prof

CONTACT

+421905512004bosten1@hotmail.com

Ilja Chandoga, MD PhD

CONTACT

+421911643354chandoga@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Boris Steno MD PhD Assoc Prof

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 5, 2020

Study Start

January 23, 2020

Primary Completion

January 23, 2022

Study Completion

March 23, 2022

Last Updated

May 5, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)