RCT Comparing the DEXA Results of the HA-Omnifit Versus the Symax Uncemented Hip Stem

Patients With Osteoarthritis of the Hip Joint Elligable for a Uncemented Hipprosthesis Clinical Trial

Official title:

A Randomized Comparative Study to Evaluate the Performance and Confirm the Safety of the Diocom Hip Syhstem in Cementless Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695213
• Other study ID #: Symax DEXA study
• Secondary ID: MEC 02-072
• Status: Completed
• Phase: Phase 4
• First received: September 25, 2012
• Last updated: September 25, 2012
• Start date: April 2003
• Est. completion date: July 2009

Study information

• Verified date: September 2012
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

Thr purpose of this study is to compare the clinical and radiological results, as well as the femur bone density measurements of two uncemented total hip prostheses during 5 years of follow up.

Description:

It is of great importance for the function of uncemented total hip arthroplasty that the anchorage of the prosthesis in the bone of the femur is sufficient. This is of great importance in the prevention of stress shielding of the bone and to insure tranfer of forces from the prosthesis to the femur.

The symax hip stem is developed to optimize stress tranfer to bone and insure mechanical stability.

In this study the symax hip stem is compared to the HA_Omnifit hip stem (a frequently used and long term evaluated uncemented hip prosthesis) During the fist two years of follow up DEXA mesurments of bone mineral density are performed. Also patient satisfaction, patient fuction score and radiological evaluation measurements are done during 5 years of follow up.

Our primary objective is: comparison of the short term bone remodelling surrounding the Symax hip stem to the short term remodeling surrounding the Stryker Omnifit HA hip stem measured by bone densitometry, clinical and radiographic evaluation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:Male or non pregnant female patients >18 years

• Patient with degenerative or traumatic changes to hip requiring hip replacement

• Patient with BMI<35

• Patient signed informed consent

Exclusion Criteria:

• chronic anti-inflammatory medication use> 3 months

• revision surgery to the affected femur

• Cancer therapy including immunosuppression, chemotherapy and radiation

• Pathological fractures, delayed ossification or non-union is likely to occur

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis, Hip
• Patients With Osteoarthritis of the Hip Joint Elligable for a Uncemented Hipprosthesis

Intervention

Procedure:
• uncemented total hip arthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Stryker European Operations BV

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	patient satisfaction	comparison of patient satisfaction between the two different prostheses	9 times within 5 years	No
Primary	short term bone remodeling	Bone remodeling is determined by measuring the Bone mineral density during time	6 times within 2 years	No
Primary	complications and reoperations	Reporting all complications and reoperations of the two different hip prostheses	during 5 years	Yes
Secondary	clinical performance	Comparison of the clinical performance of the two different hip prostheses	9 times within 5 years	No
Secondary	Radiological evaluation	Evaluation of Xrays according to the engh classifications	9 times within 5 years	No