Clinical Outcome Following Total Hip Arthroplasty With the SMF Stem

Terminated

• Conditions: Joint Diseases
• Interventions: Device: Total hip arthroplasty

• Registration Number: NCT02471703
• Lead Sponsor: Smith & Nephew, Inc.

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.

Study Timeline

• Study Start: 2008-02-27
• Study First Submitted: 2015-06-11
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-15
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SMF mini-stem hip replacement recipient	Total hip arthroplasty	Received the device via total hip arthroplasty

Primary Outcome Measures

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

Trial Locations

Locations (6)

CHUQ-L'Hôtel-Dieu de Québec; 🇨🇦 Quebec City, Quebec, Canada

ZNA Middleheim; 🇧🇪 Berchem, Belgium

Hopital Maisonneuve Rosemont, Hmr; 🇨🇦 Montreal, Quebec, Canada

St. Vincenz Hospital; 🇩🇪 Brakel, Germany

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Brüderkrankenhaus St. Josef; 🇩🇪 Paderborn, Germany