NCT01345097

Brief Summary

The investigators determined whether

  1. 1.new short, metaphyseal-fitting cementless anatomical femoral stem provides major functional improvements
  2. 2.radiographically secure implant fixation is achieved with this new stem
  3. 3.the bone content is preserved at the baseline level or above at the final follow-up
  4. 4.these procedures are associated with early failure and complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2004

Longer than P75 for phase_4

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

May 1, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

1.8 years

First QC Date

April 27, 2011

Last Update Submit

April 28, 2019

Conditions

OsteonecrosisOsteoarthritis

Keywords

short, metaphyseal-fitting femoral stemcementless anatomical femoral stemyoung patientelderly patient

Outcome Measures

Primary Outcomes (1)

  • Harris hip score

    This is a verified scoring tool for measuring hip function.

    At least 5 years after surgery

Secondary Outcomes (1)

  • Improvement in the Range of Motion

    At least 5 years after surgery

Study Arms (2)

Younger Group

EXPERIMENTAL
Device: Total Hip Arthroplasty

Elderly Group

EXPERIMENTAL
Device: Total Hip Arthroplasty

Interventions

Total Hip ArthroplastyDEVICE

Total Hip Arthroplasty

Also known as: Proxima
Elderly GroupYounger Group

Eligibility Criteria

Age20 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Osteoarthritis of hip joint requiring total hip arthroplasty

You may not qualify if:

  • Neurologic disorders affecting motor function of lower extremity foot and ankle disorders limiting ambulation of the patient
  • Patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism
  • Multi-systemic inflammatory arthritis which debilitates patients other than hip joint.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ewha Womans University Mokdong Hosptial

Seoul, 158-710, South Korea

Location

MeSH Terms

Conditions

OsteonecrosisOsteoarthritis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsArthritisJoint DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Young-Hoo Kim, MD

    Ewha Womans University Mokdong Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 27, 2011

First Posted

April 29, 2011

Study Start

May 1, 2004

Primary Completion

March 1, 2006

Study Completion

March 1, 2011

Last Updated

May 1, 2019

Record last verified: 2019-04

Locations

KR(1)