Clinical trial NCT02471703: Clinical Outcome Following Total Hip Arthroplasty With the SMF Stem
Official title: Clinical Outcome Following Total Hip Arthroplasty With the SMF Stem A Prospective, Consecutive Series, Multi-center Clinical Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Joint Diseases
Keywords: Total Hip Arthroplasty
Total Hip Replacement
Inflammatory Joint Disease
Non-Inflammatory Joint Disease
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-15
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients requiring total hip replacement.

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.

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.

Primary outcomes:
measure: Revision of the study device
timeFrame: Discharge through 10 years
measure: Device related Adverse Events
timeFrame: Implant through 10 years
measure: Harris Hip Score
timeFrame: Baseline through 10 years
measure: HOOS Questionnaire
timeFrame: Baseline through 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Berchem
country: Belgium
facility: ZNA Middleheim
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve Rosemont, Hmr
state: Quebec
city: Quebec City
country: Canada
facility: CHUQ-L'Hôtel-Dieu de Québec
state: Quebec
city: Brakel
country: Germany
facility: St. Vincenz Hospital
city: Paderborn
country: Germany
facility: Brüderkrankenhaus St. Josef
Study officials:
affiliation: Smith & Nephew, Inc.
name: Sobia Parveen
role: STUDY_CHAIR
References: