Clinical Observation Study of the Hydroxylapatite-coated SL-PLUS™ Hip Shaft (SL-PLUS HA)

Smith & Nephew

Status: Terminated

Conditions: Primary Total Hip Arthroplasty

Treatments: Device: Total Hip Arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT04121585

D10080-3

Details and patient eligibility

About

Summary from initial protocol

Goal: Validation of the HA (hydroxylapatite) coated SL-PLUS™ stem within an observation study

Study design: prospective, multicenter, observational, non-comparative study

Study population: 240 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, implant-related complications, revisions; patient questionnaires HOOS and EQ-5D

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary total hip endoprosthesis of the side affected (unilateral or bilateral)
• Patient shall be provided with a HA-coated SL-PLUS™ stem
• Patient has no general medical contraindications regarding the surgery
• Signed informed consent form for the participation in the study
• X-ray examinations are possible
• Patient is willing to participate in the post-operative follow-up program
• Age: 18-75 years

Exclusion criteria

• Previous failed hip joint surgery (endoprosthesis) of the side affected
• Previous infections in the joint affected; systemic infections

Trial design

100 participants in 1 patient group

SL-PLUS™ hydroxylapatite coated cement free hip stem

Description:

Total Hip Arthroplasty using the SL-PLUS™ hydroxylapatite coated cement free hip stem

Treatment:

Device: Total Hip Arthroplasty