Taperloc Versus Taplerloc Microplasty

This study has been completed.
Sponsor:
Collaborator:
Biomet U.K. Ltd.
Information provided by (Responsible Party):
Ingemar Ivarsson, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT00757107
First received: September 19, 2008
Last updated: March 11, 2016
Last verified: March 2016

September 19, 2008
March 11, 2016
October 2011
October 2014   (final data collection date for primary outcome measure)
Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA) [ Time Frame: [ Time Frame: bone mineral density (BMD) measured postoperatively at 2 years ] [ Designated as safety issue: No ]
Pain, Function and Range of Motion [ Time Frame: 24months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00757107 on ClinicalTrials.gov Archive Site
Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • RSA [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Survivorship [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Complication [ Time Frame: Anytime ] [ Designated as safety issue: Yes ]
  • Clinical outcome measures with Harris Hip Score comparing patients receiving different stems. [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Clinical outcome measures with Womac Score comparing patients receiving different stems. [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
Not Provided
 
Taperloc Versus Taplerloc Microplasty
Clinical Evaluation of Taperloc Total Hip System With Two Different Stem Lengths
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

Consecutive patients between 50 - 70 years diagnosed with primary osteoarthritis of the hip and eligible for total hip arthroplasty will be asked to participate in the study.

Periprosthetic bone loss, migration of the components and clinical scores will be recorded prospectively at 3,6,12 and 24 months.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis
  • Device: Taperloc Microplasty
    primary total hip arthroplasty
  • Device: Taperloc standard
    primary total hip arthroplasty
  • Experimental: Taperloc Microplasty
    Patients with primary osteoarthritis with Taperloc microplasty non inferiority
    Intervention: Device: Taperloc Microplasty
  • Active Comparator: Taperloc Standard
    Patients with primary osteoarthritis Taperloc standard
    Intervention: Device: Taperloc standard
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2015
October 2014   (final data collection date for primary outcome measure)

Inclusion criteria:

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

Exclusion Criteria

  • Malignancy or metastatic bone disease.
  • Any other disease severely affecting bone and mineral metabolism
  • Ongoing or previous treatment (within 5 years prior to inclusion) with steroids
  • Ongoing or previous treatment (within 5 years prior to inclusion) with antiresorptives.
  • Ongoing or previous treatment (within 5 years prior to inclusion) with immunosuppressive drugs.
  • Ongoing or previous treatment (within 5 years prior to inclusion) with anticonvulsive therapy.
  • Ongoing or previous treatment (within 5 years prior to inclusion) with hormonal therapy.
Both
50 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
Norway
 
NCT00757107
GBMET.CR.ROWEU1
Yes
Yes
Not Provided
Ingemar Ivarsson, University Hospital, Linkoeping
Ingemar Ivarsson
Biomet U.K. Ltd.
Principal Investigator: Ingemar IVARSSON, PhD University hospital of Linkoping
University Hospital, Linkoeping
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP