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

NCT04036071 | Terminated

• 1 other identifier: D10080-2
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 3

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.

Conditions

Primary Total Hip Arthroplasty

Keywords

HA (hydroxylapatite) coated SL-PLUS™ MIA 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

  up 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:\[1\] 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

  up 10 years 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 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

  up to patient's discharge from the hospital / clinic (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 10 years after implantation

• Survival, Kaplan Meier

  Hip implants in situ after 10 years of follow-up

  up 10 years after implantation

Secondary Outcomes (1)

• Radiographic changes defined as radiolucent lines,osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration.

  up 10 years after implantation

Interventions

Total Hip Arthroplasty DEVICE

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

Eligibility Criteria

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

Study Population

Patients requiring primary total hip arthroplasty of the affected side (unilateral or bilateral).

You may qualify if:

• 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

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 (3)

Orthopädische Landesklinik Salzburg

Salzburg, 5020, Austria

Location

Orthopädie LKH Steyr

Steyr, 4400, Austria

Location

Orthopädisches Krankenhaus Gersthof

Vienna, 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 Zweymuller

  Orthopädisches Krankenhaus Gersthof

  STUDY CHAIR

• Vinzenz v. Auersperg

  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: July 10, 2019
• First Posted: July 29, 2019
• Study Start: May 15, 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 (3)