Clinical Outcome Following Total Hip Arthroplasty With the SMF Stem (SMF-S&E)

Smith & Nephew

Status: Terminated

Conditions: Joint Diseases

Treatments: Device: Total hip arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT02471703

2011SMFH132_R11007-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

126 participants in 1 patient group

SMF mini-stem hip replacement recipient

Description:

Received the device via total hip arthroplasty

Treatment:

Device: Total hip arthroplasty