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

NCT ID: NCT01695213

Last Updated: 2012-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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uncemented hip bone remodeling DEXA clinical evaluation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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HA-Omnifit

Patients who receive a HA-Omnifit uncemented hip stem

Group Type ACTIVE_COMPARATOR

uncemented total hip arthroplasty

Intervention Type PROCEDURE

Symax hip stem

Patients with the Symax uncemented hip stem

Group Type ACTIVE_COMPARATOR

uncemented total hip arthroplasty

Intervention Type PROCEDURE

Interventions

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uncemented total hip arthroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stryker Orthopaedics

INDUSTRY

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lodewijk van Rhijn

Role: STUDY_DIRECTOR

azM

References

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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.

Reference Type DERIVED
PMID: 24378381 (View on PubMed)

Other Identifiers

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MEC 02-072

Identifier Type: OTHER

Identifier Source: secondary_id

Symax DEXA study

Identifier Type: -

Identifier Source: org_study_id