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

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.

Study Overview

• Status: Terminated
• Conditions: Primary Total Hip Arthroplasty
• Intervention / Treatment: Device: Total Hip Arthroplasty

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Austria
  • Steyr, Austria, 4400
    • Orthopädie LKH Steyr
  • Vienna, Austria, 1180
    • Orthopädisches Krankenhaus Gersthof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

240 consecutive cases (HA-coated implants), 60 cases per study site

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SL-PLUS™ hydroxylapatite coated cement free hip stem; Total Hip Arthroplasty using the SL-PLUS™ hydroxylapatite coated cement free hip stem	Device: Total Hip Arthroplasty; Total Hip Arthroplasty using the SL-PLUS™ hydroxylapatite coated cement free hip stem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Score	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.	up to 10 years after implantation
WOMAC Osteoarthritis Index	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	up to 10 yeares after implantation
EuroQuol-5D questionnaire	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	up to 10 years after implantation
Intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge	Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects	from surgery up to 7 days after surgery
Postoperative AE up to 10 years after the surgery	Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects	up to 10 years after implantation
Survival, Kaplan Meier	Hip implants in situ after 10 years of follow-up	up to 10 years after implantation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Smith & Nephew Orthopaedics AG
• Investigators: Study Chair: K Zweymüller, Univ. Prof. Dr, Orthopädisches Krankenhaus Gersthof; Principal Investigator: Vinzenz Auersperg, Prim. Dr., Orthopädie LKH Steyr

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2009
• Primary Completion (Actual): October 27, 2020
• Study Completion (Actual): October 27, 2020

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: HA (hydroxylapatite) coated SL-PLUS™ stem
• Other Study ID Numbers: D10080-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No