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

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

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.

Study Overview

• Status: Completed
• Conditions: Patients With Osteoarthritis of the Hip Joint Elligable for a Uncemented Hipprosthesis
• Intervention / Treatment: Procedure: uncemented total hip arthroplasty

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HA-Omnifit; Patients who receive a HA-Omnifit uncemented hip stem	Procedure: uncemented total hip arthroplasty
Active Comparator: Symax hip stem; Patients with the Symax uncemented hip stem	Procedure: uncemented total hip arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
short term bone remodeling	Bone remodeling is determined by measuring the Bone mineral density during time	6 times within 2 years
complications and reoperations	Reporting all complications and reoperations of the two different hip prostheses	during 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical performance	Comparison of the clinical performance of the two different hip prostheses	9 times within 5 years
Radiological evaluation	Evaluation of Xrays according to the engh classifications	9 times within 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	comparison of patient satisfaction between the two different prostheses	9 times within 5 years

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Stryker European Operations BV
• Investigators: Study Director: Lodewijk van Rhijn, azM

Publications and helpful links

General Publications

• ten Broeke RH, Tarala M, Arts JJ, Janssen DW, Verdonschot N, Geesink RG. Improving peri-prosthetic bone adaptation around cementless hip stems: a clinical and finite element study. Med Eng Phys. 2014 Mar;36(3):345-53. doi: 10.1016/j.medengphy.2013.12.006. Epub 2013 Dec 27.

Study record dates

Study Major Dates

• Study Start: April 1, 2003
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: September 25, 2012
• First Submitted That Met QC Criteria: September 25, 2012
• First Posted (Estimate): September 27, 2012

Study Record Updates

• Last Update Posted (Estimate): September 27, 2012
• Last Update Submitted That Met QC Criteria: September 25, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: DEXA; clinical evaluation; bone remodeling; uncemented hip
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: Symax DEXA study; MEC 02-072 (Other Identifier: METC MUMC Maastricht)