NCT00757107

Brief Summary

This evaluation is conducted to evaluate the safety and performance of two different stem lengths of the Taperloc Total Hip System. Per implant bone loss and migration of the stem are compared between the two groups with Dual-energy X-ray absorptiometry (DEXA) and radiostereomektric analysis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2008

Completed
3 years until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 14, 2016

Status Verified

March 1, 2016

Enrollment Period

3 years

First QC Date

September 19, 2008

Last Update Submit

March 11, 2016

Conditions

Osteoarthritis

Keywords

Short femoral stemStress shieldingStem migrationImplant SurvivalDEXARadiostereometric analysis

Outcome Measures

Primary Outcomes (1)

  • Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA) [ Time Frame:

    bone mineral density (BMD) measured postoperatively at 2 years

Secondary Outcomes (1)

  • Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis

    2 years

Other Outcomes (2)

  • Clinical outcome measures with Harris Hip Score comparing patients receiving different stems.

    3, 6, 12 and 24 months

  • Clinical outcome measures with Womac Score comparing patients receiving different stems.

    3, 6, 12 and 24 months

Study Arms (2)

Taperloc Microplasty

EXPERIMENTAL

Patients with primary osteoarthritis with Taperloc microplasty non inferiority

Device: Taperloc Microplasty

Taperloc Standard

ACTIVE COMPARATOR

Patients with primary osteoarthritis Taperloc standard

Device: Taperloc standard

Interventions

Taperloc MicroplastyDEVICE

primary total hip arthroplasty

Taperloc Microplasty
Taperloc standardDEVICE

primary total hip arthroplasty

Taperloc Standard

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with primary osteoarthritis of the hip scheduled for THA.
  • Suitable anatomy for both stems
  • Willingness and ability to follow study-protocol

You may not qualify if:

  • Malignancy or metastatic bone disease.
  • Any other disease severely affecting bone and mineral metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Linkoping

Linköping, 581 85, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ingemar IVARSSON, PhD

    University hospital of Linkoping

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 19, 2008

First Posted

September 22, 2008

Study Start

October 1, 2011

Primary Completion

October 1, 2014

Study Completion

June 1, 2015

Last Updated

March 14, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share

Locations

SE(1)