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Taperloc Versus Taplerloc Microplasty

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ClinicalTrials.gov Identifier: NCT00757107
Recruitment Status : Completed
First Posted : September 22, 2008
Last Update Posted : March 14, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
Osteoarthritis Device: Taperloc Microplasty Device: Taperloc standard

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Taperloc Total Hip System With Two Different Stem Lengths
Study Start Date : October 2011
Primary Completion Date : October 2014
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Taperloc Microplasty
Patients with primary osteoarthritis with Taperloc microplasty non inferiority
Device: Taperloc Microplasty
primary total hip arthroplasty
Active Comparator: Taperloc Standard
Patients with primary osteoarthritis Taperloc standard
Device: Taperloc standard
primary total hip arthroplasty


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis [ Time Frame: 2 years ]

Other Outcome Measures:
  1. Clinical outcome measures with Harris Hip Score comparing patients receiving different stems. [ Time Frame: 3, 6, 12 and 24 months ]
  2. Clinical outcome measures with Womac Score comparing patients receiving different stems. [ Time Frame: 3, 6, 12 and 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00757107


Locations
Sweden
University hospital of Linkoping
Linkoping, Sweden, 581 85
Sponsors and Collaborators
Ingemar Ivarsson
Biomet U.K. Ltd.
Investigators
Principal Investigator: Ingemar IVARSSON, PhD University hospital of Linkoping
More Information

Responsible Party: Ingemar Ivarsson, Associate Professor, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT00757107     History of Changes
Other Study ID Numbers: GBMET.CR.ROWEU1
First Posted: September 22, 2008    Key Record Dates
Last Update Posted: March 14, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Ingemar Ivarsson, University Hospital, Linkoeping:
Short femoral stem
Stress shielding
Stem migration
Implant Survival
DEXA
Radiostereometric analysis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases