Clinical trial NCT04122157: Prospective Single-center Long-term Observation of the SL-PLUS® MIA Stem
Official title: Prospective Single-center Long-term Observation of the SL-PLUS® MIA Stem
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Total Hip Arthroplasty
Keywords: Uncoated SL PLUS® MIA stem
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-10
Enrollment: 135
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 135 consecutive cases (uncoated SL-PLUS® MIA implants)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Survival, Kaplan Meier
timeFrame: up to 10 years after implantation
measure: Intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge
timeFrame: up to patient's discharge from the hospital/clinic (from surgery up to 7 days after surgery)
measure: Postoperative AE up to 10 years after the surgery
timeFrame: up to 10 years after implantation
Secondary outcomes:
measure: Radiographic changes defined as radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration.
timeFrame: up to 10 years after implantation
measure: Harris Hip Score
timeFrame: up to 10 years after implantation
measure: WOMAC Osteoarthritis Index
timeFrame: up to 10 years after implantation
Other outcomes:
Locations:
Study officials:
affiliation: Orthopädie LKH Steyr
name: Vinzenz v. Auersperg, Prim. Dr.
role: PRINCIPAL_INVESTIGATOR
References: