Intraoperative Case Series Study: Trial Rasp Position Versus SL-PLUS™ MIA Ti/HA Femoral Hip Stem Position

An observational study of Osteoarthritis, run by Smith & Nephew Orthopaedics AG at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A prospective, multicenter, observational study using the SL-PLUS™ MIA Ti/HA femoral hip stem with the appropriate set of instruments. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Osteoarthritis
What is being tested?: Total Hip Arthroplasty
Type of treatment: Surgery or procedure
How many people: 40 participants
Where: 3 sitesin 2 countries
Study dates: 6 Apr 2016to 7 Jun 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients enrolled in this multicenter clinical observation had at least one of the indications listed below and met all of the inclusion criteria. Patients who met any of the exclusion criteria were not eligible for this study. Indications: * Advanced hip joint wear due to degenerative, post-traumatic or rheumatoid arthritis * Fracture or avascular necrosis of the femoral head * Follow-on conditions after previous surgery such as osteosynthesis, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement.

Who may be able to join

Patient:
requires primary THA with the SL-PLUS™ MIA Ti/HA femoral hip stem
is at least 21 years of age at the time of surgery
is skeletally mature in the PI's judgment
has consented to participate in the study by signing the EC approved ICF

Who cannot join

Patient:
requires the use of a ceramic-on-ceramic bearing
has infections, acute or chronic, local or systemic
has severe muscle, nerve or vascular diseases that endanger the respective limb
has lack of bone substance or defective bone quality that jeopardizes the stable seating of the prosthesis
has any concomitant disease that may jeopardize implant function

Show all 10Show fewer

has a known allergy to study device or one or more of its components
requires a revision surgery and has extensive bone defects
has diagnosis of an immunosuppressive disorder
is pregnant

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

Germany2 sites

Charité Universitätsmedizin Berlin Centrum für Muskuloskeletale Chirurgie Klinik für Orthopädie
Berlin
Orthopädische Chirurgie München
Munich

Other trials in Germany

Austria1 site

Universitätsklinik für Orthopädie, PMU Salzburg
Salzburg

Other trials in Austria

About this study

A prospective, multicenter, observational study using the SL-PLUS™ MIA Ti/HA femoral hip stem with the appropriate set of instruments.

Read the detailed description

The study objective was to evaluate if there was a difference between the femoral position of the last trial rasp and the final implant position of the SL-PLUS™ MIA Ti/HA femoral hip stem. The femoral position of rasp or stem was considered as the height of the implant / rasp in cranio-caudal direction.

Conditions: Osteoarthritis
Being tested: Total Hip Arthroplasty
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Total Hip ArthroplastyProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Difference D Between the Position of the Last Trial Rasp and the Final Implant Position of the SL-PLUS™ MIA Ti/HA Femoral Hip Stem as Measured by an Intraoperative Fluoroscopic Measurement
Difference D was measured using standardized fluoroscopic images taken during surgery. Investigators also reported any stem position corrections made as well as type of rasping instrument used.
The difference D is given in millimeters (mm) and is defined as D = x1 - x2 with x1 being the distance between the shoulder of the trial rasp and the tip of the greater trochanter and x2 being the distance between the shoulder of the implant and the tip of the greater trochanter.
Measured: Intraoperative examination only

Secondary outcomes (2)

Number of Hips With Leg Length Discrepancy
Leg length discrepancy was measured preoperatively and postoperatively shortly after insertion of the SL-PLUS™ MIA Ti/HA femoral hip stem.
Measured: Preoperative, directly postoperative (approximately 3 months)
Number of Hips With Intraoperative Complications
Intraoperative complications were collected as a secondary outcome.
Measured: Intraoperative examination only

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Apr 20167 Jun 2017

First posted27 Jan 2016 (estimated)
Study start6 Apr 2016
Primary completion7 Jun 2017
Study completion7 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02664272
Sponsor's protocol ID: SL MIA rasp 15-4567-03
Status last verified: May 2019
First submitted: 22 Jan 2016
Last updated: 15 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intraoperative Case Series Study: Trial Rasp Position Versus SL-PLUS™ MIA Ti/HA Femoral Hip Stem Position
ClinicalTrials.gov ID: NCT02664272
Acronym / sponsor ID: SL MIA rasp 15-4567-03
Conditions: Osteoarthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
Study start: 6 Apr 2016 (actual)
Primary completion: 7 Jun 2017 (actual)
Study completion: 7 Jun 2017 (actual)
First posted: 27 Jan 2016 (estimated)
Results: Posted 15 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A prospective, multicenter, observational study using the SL-PLUS™ MIA Ti/HA femoral hip stem with the appropriate set of instruments.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients enrolled in this multicenter clinical observation had at least one of the indications listed below and met all of the inclusion criteria. Patients who met any of the exclusion criteria were not eligible for this study. Indications: * Advanced hip joint wear due to degenerative, post-traumatic or rheumatoid arthritis * Fracture or avascular necrosis of the femoral head * Follow-on conditions after previous surgery such as osteosynthesis, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement.

Key inclusion criteria (5 listed)

requires primary THA with the SL-PLUS™ MIA Ti/HA femoral hip stem
is at least 21 years of age at the time of surgery
is skeletally mature in the PI's judgment
has consented to participate in the study by signing the EC approved ICF

Key exclusion criteria (10 listed)

requires the use of a ceramic-on-ceramic bearing
has infections, acute or chronic, local or systemic
has severe muscle, nerve or vascular diseases that endanger the respective limb
has lack of bone substance or defective bone quality that jeopardizes the stable seating of the prosthesis
has any concomitant disease that may jeopardize implant function

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Total Hip Arthroplasty	Procedure or surgery	–

Primary outcome

Mean Difference D Between the Position of the Last Trial Rasp and the Final Implant Position of the SL-PLUS™ MIA Ti/HA Femoral Hip Stem as Measured by an Intraoperative Fluoroscopic Measurement
Time frame: Intraoperative examination only
Difference D was measured using standardized fluoroscopic images taken during surgery. Investigators also reported any stem position corrections made as well as type of rasping instrument used. The difference D is given in millimeters (mm) and is defined as D = x1 - x2 with x1 being the distance between the shoulder of the trial rasp and the tip of the greater trochanter and x2 being the distance between the shoulder of the implant and the tip of the greater trochanter.

2 secondary outcomes

Number of Hips With Leg Length Discrepancy
Time frame: Preoperative, directly postoperative (approximately 3 months)
Number of Hips With Intraoperative Complications
Time frame: Intraoperative examination only

Results and safety

Results posted to the registry on 15 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SL-PLUS™ MIA Ti/HA	40	38

Primary outcome: Mean Difference D Between the Position of the Last Trial Rasp and the Final Implant Position of the SL-PLUS™ MIA Ti/HA Femoral Hip Stem as Measured by an Intraoperative Fluoroscopic Measurement

Time frame: Intraoperative examination only. Mean (95% Confidence Interval). Unit: mm

Measure	SL-PLUS™ MIA Ti/HA n = 38
Distance X1 (trial rasp)(mm)	7.78 (6.15 to 9.40)
Distance X2 (stem)(mm)	5.15 (3.52 to 6.78)
Difference D	2.63 (1.89 to 3.37)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of preoperative examinations (Baseline) until directly postoperatively (time frame of approximately 3 months enrollment period).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SL-PLUS™ MIA Ti/HA	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Limitations and caveats (from the sponsor): Basic fluoroscopic image analysis (intrinsic: resolution/technique and extrinsic: alignment/orientation to landmarks). The Guide to the Expression of Uncertainty in Measurement (GUM) was followed to estimate the combined uncertainty of the method.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Not yet recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andy Weymann, MD, MBA study director

Smith & Nephew Orthopaedics AG

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis, run by Smith & Nephew Orthopaedics AG at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Difference D Between the Position of the Last Trial Rasp and the Final Implant Position of the SL-PLUS™ MIA Ti/HA Femoral Hip Stem as Measured by an Intraoperative Fluoroscopic Measurement (time frame: Intraoperative examination only). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02664272.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.