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

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

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

Study Overview

• Status: Terminated
• Conditions: Joint Diseases
• Intervention / Treatment: Device: Total hip arthroplasty

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 Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

Study Locations

• Belgium
  • Berchem, Belgium, 2600
    • ZNA Middleheim
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C1R6
      • St. Michael's Hospital
  • Quebec
    • Montreal, Quebec, Canada, 5701
      • Hopital Maisonneuve Rosemont, Hmr
    • Quebec City, Quebec, Canada, G1R 2J6
      • CHUQ-L'Hotel-Dieu de Quebec
• Germany
  • Brakel, Germany, 22024
    • St. Vincenz Hospital
  • Paderborn, Germany, 33098
    • Brüderkrankenhaus St. Josef

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients requiring total hip replacement.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SMF mini-stem hip replacement recipient; Received the device via total hip arthroplasty	Device: Total hip arthroplasty; Total hip arthroplasty; Other Names: Total hip replacement

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Chair: Sobia Parveen, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 27, 2008
• Primary Completion (ACTUAL): February 1, 2020
• Study Completion (ACTUAL): February 1, 2020

Study Registration Dates

• First Submitted: June 11, 2015
• First Submitted That Met QC Criteria: June 11, 2015
• First Posted (ESTIMATE): June 15, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Total Hip Arthroplasty; Total Hip Replacement; Inflammatory Joint Disease; Non-Inflammatory Joint Disease
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 2011SMFH132_R11007-1