Prospective Single-center Long-term Observation of the SL-PLUS® MIA Stem

Primary Total Hip Arthroplasty Clinical Trial

— SL-PLUS MIA  

Official title:

Prospective Single-center Long-term Observation of the SL-PLUS® MIA Stem

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04122157
• Other study ID #: D10055-2
• Status: Completed
• Start date: July 22, 2007
• Est. completion date: November 11, 2019

Study information

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

Clinical Trial Summary

Summary from initial protocol

Goal: Validation of the uncoated SL-PLUS® MIA stem within an observation study

Study design: prospective, single-center, observational, non-comparative study

Study population: 135 consecutive cases (uncoated SL-PLUS® MIA implants)

Intervention (if applicable): Implantation of a total hip endoprosthesis

Main goals/endpoints: Radiological: radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration; clinical: Harris Hip Score, implant-related complications, revisions; patient questionnaire (WOMAC)

Type and extent of the risks associated with the study participation as well as benefits for the patient: All patients will benefit from the hip prostheses without exception. There are no increased risks for the patients participating in the study compared to patients who do not participate. Normal, necessary follow-up exams will be performed over the course of 10 years. These follow-up exams will then be quantitatively evaluated within the scope of the study in accordance with a standardized protocol. Accordingly, the benefit for the patients from the participation in the study is currently not yet foreseeable.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: November 11, 2019
• Est. primary completion date: November 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with primary or secondary hip osteoarthritis

• Patients scheduled for a first implantation

• Age at the time of surgery 40-80 years

Exclusion Criteria:

• Destruction of the acetabulum

• Deformation of the hip joint

• Deformation of the proximal femur

• Revision of failed hip endoprostheses

• Acute or recent infection of the joint or its surrounding region

• Acute or chronic systemic infections

• Marked atrophy or deformation of the upper femur

• Muscle atrophy or a neuromuscular disease

• Pathological fractures

• Per- to subtrochanteric fractures

• Conditions that would prevent secure anchoring of the hip prosthesis

• Obese patients with a BMI >35

• Patients not expected to have a successful rehabilitation

Related Conditions & MeSH terms

• Primary Total Hip Arthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew Orthopaedics AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival, Kaplan Meier	Survival rate: Rate of hip implants in situ after 10 years of follow-up.	up to 10 years after implantation
Primary	Intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge	Rate of hip implant experiencing intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge.; Rate of hip implants with Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects	up to patient's discharge from the hospital/clinic (from surgery up to 7 days after surgery)
Primary	Postoperative AE up to 10 years after the surgery	Rate of hip implants experiencing Postoperative AE up to 10 years after the surgery Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects	up to 10 years after implantation
Secondary	Radiographic changes defined as radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration.	Rate of hip implants with radiographic changes defined as radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration.	up to 10 years after implantation
Secondary	Harris Hip Score	The Harris Hip Score (HHS) is a clinician-based outcome measure frequently used for the evaluation of patients following a total hip arthroplasty.The score considers information on pain, function and range of motion. The scale ranges from 0 - 100 whereas, a higher score indicates a favorable outcome.	up to 10 years after implantation
Secondary	WOMAC Osteoarthritis Index	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on I off toilet, heavy domestic duties, light domestic duties. The scale ranges from 0 - 100 whereas, a higher score indicates a favorable outcome.	up to 10 years after implantation