Clinical trial NCT04172129: Assessment of Implant Fixation and SF-36 for Short Hip-Stems - A Prospective Clinical Study
Official title: Assessment of Implant Fixation and SF-36 for Short Hip-Stems - A Prospective Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary and Secondary Coxarthrosis
Dysplasia Coxarthrosis
Post-traumatic Necrosis of the Femoral Head
Keywords: Nanos
THA
MBRSA
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients identified in the primary care clinic with need for total hip arthroplasty

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of migration pattern of the Nanos stem
timeFrame: 2 years
measure: Change in quality of life
timeFrame: 2 years
Secondary outcomes:
measure: Harris Hip Score
timeFrame: 2 years
measure: University of California, Los Angeles (UCLA) scale
timeFrame: 2 years
measure: Pain Visual Analogue Scale
timeFrame: 2 years
measure: Postel Merle d'Aubigné-Score
timeFrame: 2 years
measure: Hip Disability and Ostheoarthritis Outcome Score
timeFrame: 2 years
measure: Radiographic Evaluation
timeFrame: 2 years
measure: Number of adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Orthopädische Klinik der Medizinischen Hochschule Hannover
Study officials:
affiliation: Orthopädische Klinik der Medizinischen Hochschule Hannover
name: Henning Windhagen, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: