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OpenTrials
Completed

NCT Number: NCT00757107

Taperloc Versus Taplerloc Microplasty

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

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital of Linkoping

Linköping, 581 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Taperloc Microplasty

Device

primary total hip arthroplasty

Taperloc standard

Device

primary total hip arthroplasty

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:

    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

    Time frame: 2 years

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Ingemar Ivarsson

Other

Collaborators

  • Biomet U.K. Ltd.

Registry information

Official study title

Clinical Evaluation of Taperloc Total Hip System With Two Different Stem Lengths

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Sep 22, 2008
Registry last updated
Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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