Taperloc Versus Taplerloc Microplasty

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757107
• Other study ID #: GBMET.CR.ROWEU1
• Status: Completed
• Phase: N/A
• First received: September 19, 2008
• Last updated: March 11, 2016
• Start date: October 2011
• Est. completion date: June 2015

Study information

• Verified date: March 2016
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Taperloc Microplasty
primary total hip arthroplasty
• Taperloc standard
primary total hip arthroplasty

Locations

Country	Name	City	State
Sweden	University hospital of Linkoping	Linkoping

Sponsors (2)

Lead Sponsor	Collaborator
Ingemar Ivarsson	Biomet U.K. Ltd.

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical outcome measures with Harris Hip Score comparing patients receiving different stems.		3, 6, 12 and 24 months	No
Other	Clinical outcome measures with Womac Score comparing patients receiving different stems.		3, 6, 12 and 24 months	No
Primary	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	No
Secondary	Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis		2 years	No