Assessment of Implant Fixation and SF-36 for Short Hip-Stems

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

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-26

Study Completion Date

2017-02-15

Brief Summary

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The primary purpose of this study was to evaluate the implant fixation of the NANOS™ Neck Preserving Hip Stem (OHST Medizintechnik AG, distributed by Smith \& Nephew GmbH, Marl, Germany) by measuring the migration of the implant using the model-based roentgen stereophotogrammetric analysis (MBRSA).

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Detailed Description

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Conditions

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Primary and Secondary Coxarthrosis Dysplasia Coxarthrosis Post-traumatic Necrosis of the Femoral Head

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NANOS

NANOS™ Neck Preserving Hip Stem

Total Hip Arthroplasty

Intervention Type DEVICE

Interventions

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Total Hip Arthroplasty

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject required primary total hip arthroplasty unilateral or bilateral with a diagnosis of primary and secondary coxarthrosis, dysplasia coxarthrosis and post-traumatic necrosis of the femoral head confirmed by x-ray analysis. For bilateral subjects at least three months between surgical procedures were required.
* Subject was willing to consent to participate in the study and planned to be available for the follow-up examinations.
* Subject had normal motor function of the lower extremities, documented through clinical examinations and lack of signs of a neurological disease with changed motor function.
* Subject was 30 to 65 (inclusive) years of age at time of surgery.

Exclusion Criteria

* Subject had previous bone or soft tissue surgery of the affected hip except for arthroscopic surgery.
* Subject had a local or systemic infection.
* Subject had previously diagnosed osteoporosis.
* Subject had a femoral neck angle of \>145°.
* Subject had a femoral neck angle of \<125°.
* Subject had a disease of the cardiovascular system involving particularly reduced load capacity in the everyday life, counting as contraindication of physical stress (American Society of Anaesthesiologists' (ASA) Score 3 or 4).
* Subject had a documented allergy against elements of the implanted device.
* Subject had a neurological disease with changed motor function.
* Subject was pregnant.
* Subject had a Body Mass Index (BMI) \> 30.
* Subject suffered from alcoholism or addictive disorders.
* Subject needed a revision hip arthroplasty.
* Subject had an insufficient command of the language to understand patient information and consent.

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No