NCT02471703

Brief Summary

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2008

Longer than P75 for all trials

Geographic Reach
3 countries

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2008

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

11.9 years

First QC Date

June 11, 2015

Last Update Submit

February 17, 2021

Conditions

Joint Diseases

Keywords

Total Hip ArthroplastyTotal Hip ReplacementInflammatory Joint DiseaseNon-Inflammatory Joint Disease

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

SMF mini-stem hip replacement recipient

Received the device via total hip arthroplasty

Device: Total hip arthroplasty

Interventions

Total hip arthroplastyDEVICE

Total hip arthroplasty

Also known as: Total hip replacement
SMF mini-stem hip replacement recipient

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients requiring total hip replacement.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

ZNA Middleheim

Berchem, 2600, Belgium

Location

St. Michael's Hospital

Toronto, Ontario, M5C1R6, Canada

Location

Hopital Maisonneuve Rosemont, Hmr

Montreal, Quebec, 5701, Canada

Location

CHUQ-L'Hôtel-Dieu de Québec

Québec, Quebec, G1R 2J6, Canada

Location

St. Vincenz Hospital

Brakel, 22024, Germany

Location

Brüderkrankenhaus St. Josef

Paderborn, 33098, Germany

Location

MeSH Terms

Conditions

Joint Diseases

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Sobia Parveen

    Smith & Nephew, Inc.

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2015

First Posted

June 15, 2015

Study Start

February 27, 2008

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

CA(3)BE(1)DE(2)