NCT02087436

Brief Summary

The primary purpose of this study is to measure the postoperative changes in bone mineral density, comparing the Taperloc Complete Reduced Distal Microplasty stem and the standard length Taperloc Complete Reduced Distal stem.

Trial Health

87
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
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 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

March 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 9, 2020

Status Verified

July 1, 2019

Enrollment Period

1.3 years

First QC Date

January 14, 2014

Last Update Submit

January 6, 2020

Conditions

OsteoarthritisAvascular NecrosisTraumatic ArthritisRheumatoid ArthritisLegg-Perthes Disease

Outcome Measures

Primary Outcomes (1)

  • Bone Mineral Density

    evaluate bone mineral density around the implant

    1 year

Secondary Outcomes (11)

  • Radiographic Evaluation,

    2 years

  • VAS Score

    2 years

  • Modified Harris Hip Score

    2 years

  • Radiographic Evaluation

    1 year

  • Radiographic Evaluation

    6 Weeks

  • +6 more secondary outcomes

Study Arms (2)

Taperloc Complete Standard

ACTIVE COMPARATOR

Group one will receive a total hip replacement with Taperloc Complete Standard. Taperloc Complete Standard is designed after the philosophy of a flat tapered wedge. It has evolved to incorporate the Reduced Distal and Microplasty stems to better address all patient anatomies, and facilitate multiple surgical techniques.

Device: Taperloc Complete Standard

Taperloc Complete Microplasty

ACTIVE COMPARATOR

Group one will receive a total hip replacement with Taperloc Complete Microplasty.Taperloc Complete Microplsty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption.

Device: Taperloc Complete Microplasty

Interventions

Taperloc Complete MicroplastyDEVICE

Taperloc Complete Microplsty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption.

Taperloc Complete Microplasty
Taperloc Complete StandardDEVICE

Taperloc Complete Standard is designed after the philosophy of a flat tapered wedge. It has evolved to incorporate the Reduced Distal and Microplasty stems to better address all patient anatomies, and facilitate multiple surgical techniques.

Taperloc Complete Standard

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suitable for primary Total Hip Replacement
  • Patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of:
  • Osteoarthritis
  • Avascular necrosis
  • Legg Perthes
  • Rheumatoid Arthritis
  • Diastrophic variant
  • Fused hip
  • Sequelae of Slipped capital epiphysis
  • Traumatic arthritis
  • Patients aged over 20
  • Patients must be able to understand instructions and be willing to return for follow-up

You may not qualify if:

  • Absolute contraindications include: infection, sepsis, and osteomyelitis.
  • Relative contraindications include:
  • uncooperative patient or patient with neurologic disorders who are incapable of following directions,
  • Small Femoral canal
  • \) Severe osteoporosis (Patients over 65 years old) 3) metabolic disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and 7) vascular insufficiency, muscular atrophy, or neuromuscular disease. 8) pregnancy 9) Fracture of the pelvis 10) Subcapital fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Location

Chung-Ang University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

OsteoarthritisOsteonecrosisArthritis, RheumatoidLegg-Calve-Perthes Disease

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesFemur Head Necrosis

Study Officials

  • Yong-Chan Ha, PHD

    Chung-Ang University Hosptial, Chung-Ang University College of Medicine

    PRINCIPAL INVESTIGATOR

  • Young-Kyun Lee, PHD

    Seoul National University Bundang 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
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2014

First Posted

March 14, 2014

Study Start

March 1, 2013

Primary Completion

July 1, 2014

Study Completion

December 1, 2019

Last Updated

January 9, 2020

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)