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

NCT04122157 | Completed

• 1 other identifier: D10055-2
• Study Type: observational
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Primary Total Hip Arthroplasty

Keywords

Uncoated SL PLUS® MIA stem

Outcome Measures

Primary Outcomes (3)

• Survival, Kaplan Meier

  Survival rate: Rate of hip implants in situ after 10 years of follow-up.

  up to 10 years after implantation

• 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)

• 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 Outcomes (2)

• 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

• Harris Hip Score

  up to 10 years after implantation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with primary or secondary hip osteoarthritis
• Patients scheduled for a first implantation
• Age at the time of surgery 40-80 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew Orthopaedics AG: lead

Study Officials

• Vinzenz v. Auersperg, Prim. Dr.

  Orthopädie LKH Steyr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 10, 2019
• Study Start: July 22, 2007
• Primary Completion: November 11, 2019
• Study Completion: November 11, 2019
• Last Updated: January 6, 2026

Record last verified: 2021-02