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

Terminated

• Conditions: Primary Total Hip Arthroplasty
• Interventions: Device: Total Hip Arthroplasty

• Registration Number: NCT04121585
• Lead Sponsor: Smith & Nephew Orthopaedics AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-12
• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-10-08
• Study First Posted: 2019-10-10
• 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: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
WOMAC Osteoarthritis Index	up to 10 yeares 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: 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 I off toilet, heavy domestic duties, light domestic duties
EuroQuol-5D questionnaire	up to 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
Postoperative AE up to 10 years after the surgery	up to 10 years after implantation	Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects
Harris Hip Score	up to 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. The score considers information on pain, function and range of motion. The scale ranges from 0 - 100 whereas, a higher score indicates a favorable outcome.
Intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge	from surgery up to 7 days after surgery	Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects
Survival, Kaplan Meier	up to 10 years after implantation	Hip implants in situ after 10 years of follow-up

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Orthopädisches Krankenhaus Gersthof; 🇦🇹 Vienna, Austria

Orthopädie LKH Steyr; 🇦🇹 Steyr, Austria