CompletedNot Applicable

Prospective Single-center Long-term Observation of the SL-PLUS® MIA Stem

135 participantsStarted 2007-07-22

Plain-language summary

Summary from initial protocol Goal: Validation of the uncoated SL-PLUS® MIA stem within an observation study Study design: prospective, single-center, observational, non-comparative study Study population: 135 consecutive cases (uncoated SL-PLUS® MIA implants) 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 questionnaire (WOMAC) 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.

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with primary or secondary hip osteoarthritis * Patients scheduled for a first implantation * Age at the time of surgery 40-80 years Exclusion Criteria: * Destruction of the acetabulum * Deformation of the hip joint * Deformation of the proximal femur * Revision of failed hip endoprostheses * Acute or recent infection of the joint or its surrounding region * Acute or chronic systemic infections * Marked atrophy or deformation of the upper femur * Muscle atrophy or a neuromuscular disease * Pathological fractures * Per- to subtrochanteric fractures * Conditions that would prevent secure anchoring of the hip prosthesis * Obese patients with a BMI \>35 * Patients not expected to have a successful rehabilitation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Survival, Kaplan Meier

Timeframe: up to 10 years after implantation

Intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge

Timeframe: 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

Timeframe: up to 10 years after implantation

Trial details

NCT IDNCT04122157

SponsorSmith & Nephew Orthopaedics AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-11-11

View on ClinicalTrials.gov More Primary Total Hip Arthroplasty trials

Plain-language summary

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Survival, Kaplan Meier

Timeframe: up to 10 years after implantation

Intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge

Timeframe: 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

Timeframe: up to 10 years after implantation