Clinical Outcome Following Total Hip Arthroplasty With the SMF Stem

Study Overview
=================
Brief Summary
-----------------
This is a prospective, consecutive series, multicenter clinical study of clinical outcomes following total hip arthroplasty with the SMF stem.

Detailed Description
-----------------
The objectives of this study are to evaluate the safety and efficacy of the study device. This study will document any device-related, surgical or post-operative complication and adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems. Outcome measures will be quantified through statistical analysis of study device , HOOS questionnaire, radiographic assessments, Harris Hip Score, and adverse event reports.

Official Title
-----------------
Clinical Outcome Following Total Hip Arthroplasty With the SMF Stem A Prospective, Consecutive Series, Multi-center Clinical Study

Conditions
-----------------
Joint Diseases

Intervention / Treatment
-----------------
* Device: Total hip arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient presents with non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, avascular necrosis, rheumatoid arthritis of or any of it's composite diagnosis. Patient is of legal age to consent, is skeletally mature and at least 18 years old. Patient is willing to consent to participate in the study by signing and dating an IRB-approved consent form. Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological or other conditions that would pose excessive operative risk. Exclusion Criteria: Patient has poor bone stock and would make the procedure unjustifiable: A) patients which are under medical care for osteoporosis (taking hormones, Calcitonin or biphosphates) or for other metabolic pathologies, which could influence the quality of the bone (for example hyperparathyroidism, hyperthyreoidismus and osteomalacie) will be excluded from the study. B) patients suffering from Morbus Paget (osteodystrophia deformans) will be excluded from the study. Patient has conditions that tend to place increased loads on implants such as weight, chargot joint, muscular deficiencies and activity level, which are incompatible with a satisfactory long-term result: A) patients with a BMI > 40 will be excluded from the study B) patients participating in high-impact sports like baseball, basketball, football, handball, hockey, karate, racquet-ball, running, soccer, water skiing or similar impact sports will be excluded from the study. Patient is over the age of 75. Skeletal immaturity: patients must be at least 18 years at the time of the operation. Patient has an active, local infection that would lead to increased bone resorption. Mental or neurological conditions that tend to pre-empt the patient's ability or willingness to restrict activities. Known sensitivity to materials of the implant. Patient is pregnant or plans to be come pregnant during the course of the study. Patient is a prisoner.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SMF mini-stem hip replacement recipient<br>Received the device via total hip arthroplasty | Device: Total hip arthroplasty<br>* Total hip arthroplasty<br>* Other names: Total hip replacement;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revision of the study device | Instances of required revision of the study device | Discharge through 10 years | 
| Device related Adverse Events | surgical, device-related, death and serious adverse events will be analyzed | Implant through 10 years | 
| Harris Hip Score | Questionnaire to calculate pain, walking abilities, activities, degrees of hip motion | Baseline through 10 years | 
| HOOS Questionnaire | Questionnaire to calculate hip symptoms, stiffness, pain, function and quality of life | Baseline through 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Hip Arthroplasty, Total Hip Replacement, Inflammatory Joint Disease, Non-Inflammatory Joint Disease