This trial is active, not recruiting.

Condition joint diseases
Treatment total hip arthroplasty
Sponsor Smith & Nephew, Inc.
Start date September 2010
End date December 2025
Trial size 126 participants
Trial identifier NCT02471703, CR-132


This is a prospective, consecutive series, multicenter clinical study of clinical outcomes following total hip arthroplasty with the SMF stem.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Received the device via total hip arthroplasty
total hip arthroplasty Total hip replacement
Total hip arthroplasty

Primary Outcomes

Revision of the study device
time frame: Discharge through 10 years
Device related Adverse Events
time frame: Implant through 10 years
Harris Hip Score
time frame: Baseline through 10 years
HOOS Questionnaire
time frame: Baseline through 10 years

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title Clinical Outcome Following Total Hip Arthroplasty With the SMF Stem
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Smith & Nephew, Inc..