Clinical Observation Study of the Hydroxylapatite-coated SLPLUS™MIA Hip Shaft (SL-Plus HA MIA)

Smith & Nephew

Status

Terminated

Conditions

Primary Total Hip Arthroplasty

Treatments

Device: Total Hip Arthroplasty

Study type

Observational

Funder types

Industry

Identifiers

NCT04036071

D10080-2

Details and patient eligibility

About

Summary from initial protocol Goal: Validation of the HA (hydroxylapatite) coated SLPLUS

™ MIA stem within an observation study Study design: prospective, multicenter, observational, noncomparative study Study population: 300 consecutive cases (HA-coated implants), 60 cases per study site. 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, HOOS Score, EQ-5D, implant-related complications, revisions 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. In addition, study patients are asked to provide information on their general state of health and the condition of their hip in two questionnaires. These clinical and radiological follow-up exams will then be quantitatively evaluated within the scope of the study in accordance with a standardized protocol. Accordingly, the direct benefit for the patients from the participation in the study is currently not yet foreseeable.

Enrollment

165 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria