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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
  Purpose
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 Intervention
Osteoarthritis
Device: Taperloc Microplasty
Device: Taperloc standard

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Taperloc Total Hip System With Two Different Stem Lengths

Resource links provided by NLM:


Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: October 2011
Study Completion Date: June 2015
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: September 19, 2008
Last Updated: March 11, 2016
Health Authority: Sweden: Medical Products Agency
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by 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

ClinicalTrials.gov processed this record on December 06, 2016