NCT03442855

Brief Summary

Prospective observational (non-interventional) cohort study, multi-centric in 5 study Centers in Japan to collect short term clinical and radiological results of the cementless Bicontact® E stem in a standard patient population used in routine clinical practice

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

5 active sites

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

February 1, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 6, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

February 6, 2018

Last Update Submit

September 18, 2019

Conditions

Degenerative OsteoarthritisRheumatoid ArthritisFemoral Neck FracturesFemoral Head Necrosis

Keywords

Arthroplasty, Replacement, Hip

Outcome Measures

Primary Outcomes (1)

  • Clinical Results

    Hip Score of the Japanese Orthopaedic Association (JOA): three categories-movement, mental, and pain-each comprising 7 items, for a total of 21 items to be used as evaluation criteria for hip-joint function

    1 year

Secondary Outcomes (3)

  • Thigh Pain

    1 year

  • X-Ray evaluation

    1 year

  • (Serious) Adverse Events

    1 year

Eligibility Criteria

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

Patients receiving primary THA: Acute disorders of the hip that cannot be treated by other therapies: * Degenerative osteoarthritis * Rheumatic arthritis * Joint fractures * Femoral head necrosis

You may qualify if:

  • Indication for Bicontact E prosthesis THA
  • Patients ≥ 18 years
  • Patient not pregnant
  • Written informed consent

You may not qualify if:

  • \- Patients receiving a bipolar implantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Funabashi Orthopedic Hospital

Funabashi, Japan

Location

Niigata Bandai Hospital

Niigata, Japan

Location

Niigata Rinko Hospital

Niigata, Japan

Location

Niigata Univ. Medical & Dental Hospital

Niigata, Japan

Location

Saiseikai Niigata Second Hospital

Niigata, Japan

Location

MeSH Terms

Conditions

Joint DiseasesArthritis, RheumatoidFemoral Neck Fractures

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesArthritisRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesHip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 22, 2018

Study Start

February 1, 2017

Primary Completion

May 31, 2018

Study Completion

May 31, 2019

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations

JP(5)