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

NCT04121585 | Terminated

• 1 other identifier: D10080-3
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Primary Total Hip Arthroplasty

Keywords

HA (hydroxylapatite) coated SL-PLUS™ stem

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Radiographic changes

  up to 10 years after implantation

Study Arms (1)

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

Interventions

Total Hip Arthroplasty DEVICE

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

SL-PLUS™ hydroxylapatite coated cement free hip stem

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Smith & Nephew Orthopaedics AG: lead

Study Sites (2)

Orthopädie LKH Steyr

Steyr, 4400, Austria

Location

Orthopädisches Krankenhaus Gersthof

Vienna, 1180, Austria

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• K Zweymüller, Univ. Prof. Dr

  Orthopädisches Krankenhaus Gersthof

  STUDY CHAIR

• Vinzenz Auersperg, Prim. Dr.

  Orthopädie LKH Steyr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 10, 2019
• Study Start: June 12, 2009
• Primary Completion: October 27, 2020
• Study Completion: October 27, 2020
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)