Clinical Outcome Following Total Hip Arthroplasty With the SMF Stem

Joint Diseases Clinical Trial

— SMF-S&E  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02471703
• Other study ID #: 2011SMFH132_R11007-1
• Status: Terminated
• Start date: February 27, 2008
• Est. completion date: February 1, 2020

Study information

• Verified date: February 2021
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, consecutive series, multicenter clinical study of clinical outcomes 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 126
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases

Intervention

Device:
• Total hip arthroplasty
Total hip arthroplasty

Locations

Country	Name	City	State
Belgium	ZNA Middleheim	Berchem
Canada	Hopital Maisonneuve Rosemont, Hmr	Montreal	Quebec
Canada	CHUQ-L'Hôtel-Dieu de Québec	Quebec City	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Germany	St. Vincenz Hospital	Brakel
Germany	Brüderkrankenhaus St. Josef	Paderborn

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Countries where clinical trial is conducted

Belgium,  Canada,  Germany, 

Outcome

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