Clinical Observation Study of the Hydroxylapatite-coated SLPLUS™MIA Hip Shaft

Terminated

• Conditions: Primary Total Hip Arthroplasty

• Registration Number: NCT04036071
• Lead Sponsor: Smith & Nephew Orthopaedics AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-15
• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-24
• Study First Posted: 2019-07-29
• Primary Completion: 2020-10-27
• Study Completion: 2020-10-27
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• Primary total hip endoprosthesis of the side affected (unilateral or bilateral)
• Patient shall be provided with a HA coated SLPLUS™ MIA 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EuroQuol-5D questionnaire	up 10 years after implantation	EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal
Intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge	up to patient's discharge from the hospital / clinic (from surgery up to 7 days after surgery)	Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects
Harris Hip Score	up 10 years after implantation	The Harris Hip Score (HHS) is a clinician-based outcome measure frequently used for the evaluation of patients following a total hip arthroplasty
WOMAC Osteoarthritis Index	up 10 years after implantation	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:\[1\]; 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 / off toilet, heavy domestic duties, light domestic duties
Postoperative AE up to 10 years after the surgery	up 10 years after implantation	Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects
Survival, Kaplan Meier	up 10 years after implantation	Hip implants in situ after 10 years of follow-up

Secondary Outcome Measures

Name	Time	Method
Radiographic changes defined as radiolucent lines,osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration.	up 10 years after implantation

Trial Locations

Locations (3)

Orthopädische Landesklinik Salzburg; 🇦🇹 Salzburg, Austria

Orthopädie LKH Steyr; 🇦🇹 Steyr, Austria

Orthopädisches Krankenhaus Gersthof; 🇦🇹 Vienna, Austria