Osteoarthritis, HipNCT04079114

Post Market Clinical Follow-Up of the Zimmer Stafit Acetabular System

An observational study of Osteoarthritis, Hip and Fracture of Hip, run by Zimmer Biomet.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoarthritis, Hip, Fracture of Hip, Avascular Necrosis of Hip
What is being tested?: Patients who received the Stafit Acetabular System
Type of treatment: Medical device
How many people: 166 participants
Where: No sites listed yet
Study dates: 28 Apr 2011to 15 Jul 2019
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 18 years and older
All sexes
Adult, Older adult

Study population: Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.

Who may be able to join

Males and females
Patients suffering from severe hip pain and disability requiring a primary total hip arthroplasty.
18 years minimum
Patients able to participate in a follow-up program based upon physical examination and medical history
Patients who have provided written informed consent by signing the Patient Informed Consent Form.

Who cannot join

Patients who are unwilling or unable to give informed consent, or to comply with the follow-up program
Known pregnancy
Revision hip arthroplasty

About this study

Official title: Post Market Clinical Follow-Up Study of the Zimmer Stafit Acetabular System. A Multicenter, Prospective, Non-controlled Study

This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2. The data collected from this study will serve the purpose of confirming safety and performance of the Zimmer Stafit Acetabular System.

Read the detailed description

The objective of this study is to obtain implant survival and outcome data on the Stafit Acetabular System by analysis of standard scoring systems, radiographs, and adverse event records.

Data will be used to monitor pain, mobility, dislocation rate and implant survival, and to confirm the long-term safety and performance of the Stafit Acetabular System in primary total hip arthroplasty.

The study design is a multi-center, prospective, non-controlled, consecutive cohort post market clinical follow-up study, involving orthopedic surgeons skilled in total hip arthroplasty procedures and experienced with the Stafit Acetabular System.

Conditions: Osteoarthritis, Hip, Fracture of Hip, Avascular Necrosis of Hip, Dislocated Hip, Osteonecrosis, Post-traumatic; Arthrosis
Being tested: Patients who received the Stafit Acetabular System
Medical subject headings: Osteoarthritis, Hip, Hip Fractures, Hip Dislocation, Osteonecrosis, Osteoarthritis, Arthritis, Rheumatoid

What participants receive

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

Patients who received the Stafit Acetabular SystemDevice
Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.

What is being measured

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

Implant Survival
Represents the implants that survived by counting the number of implants revised.
Measured: 3 years postoperatively, due to early study termination
Dislocation Rate
Assessed by counting the number of implant dislocations
Measured: 2 years

Secondary outcomes (2)

Evaluation of Pain and Functional Performance Determined by the Harris Hip Score
The Harris Hip Score is a questionnaire filled by the surgeon on the patients who received a hip implant. The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication.
The function domain consists of daily activities (stairs, public transportation, sitting, and managing shoes and socks) and gait (limp, support needed for walking, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction.
There are 10 items. The score has a minimum of 0 (worst possible score) to a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).
Measured: 3 years postoperatively, due to early study termination
Confirmation of Safety Based on Complications
Reported number of patients with adverse events related to the implant. Adverse events include: dislocations of the hip, revisions and removals of the implants
Measured: 3 years postoperatively, due to early study termination

Timeline

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

28 Apr 201115 Jul 2019

First posted6 Sep 2019
Study start28 Apr 2011
Primary completion24 Jan 2017
Study completion15 Jul 2019

Why it stopped: Stafit Acetabular System not CE marked anymore

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 Osteoarthritis, HipStudies of the same condition, open and under way.
More trials run by Zimmer BiometThe sponsor's other registered studies.
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: Cohort
Time perspective: Prospective
Enrolment: 166 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04079114
Sponsor's protocol ID: 09H07
Status last verified: Jun 2020
First submitted: 2 Sep 2019
Last updated: 30 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: 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?

Official record

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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
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All Osteoarthritis, Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Market Clinical Follow-Up Study of the Zimmer Stafit Acetabular System. A Multicenter, Prospective, Non-controlled Study
ClinicalTrials.gov ID: NCT04079114
Acronym / sponsor ID: 09H07
Conditions: Osteoarthritis, Hip, Fracture of Hip, Avascular Necrosis of Hip, Dislocated Hip, Osteonecrosis, Post-traumatic; Arthrosis
Study type: Observational
Recruitment status: TerminatedReason stopped: Stafit Acetabular System not CE marked anymore
Enrolment: 166 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: 28 Apr 2011 (actual)
Primary completion: 24 Jan 2017 (actual)
Study completion: 15 Jul 2019 (actual)
First posted: 6 Sep 2019 (actual)
Results: Posted 30 Jun 2020

Clinical summary

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

Detailed description

The objective of this study is to obtain implant survival and outcome data on the Stafit Acetabular System by analysis of standard scoring systems, radiographs, and adverse event records.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
Study population: Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.

Key inclusion criteria (5 listed)

Males and females
Patients suffering from severe hip pain and disability requiring a primary total hip arthroplasty.
18 years minimum
Patients able to participate in a follow-up program based upon physical examination and medical history
Patients who have provided written informed consent by signing the Patient Informed Consent Form.

Key exclusion criteria (3 listed)

Patients who are unwilling or unable to give informed consent, or to comply with the follow-up program
Known pregnancy
Revision hip arthroplasty

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
Patients who received the Stafit Acetabular SystemPatients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.	Device	–

Primary outcome

Implant Survival
Time frame: 3 years postoperatively, due to early study termination
Represents the implants that survived by counting the number of implants revised.
Dislocation Rate
Time frame: 2 years
Assessed by counting the number of implant dislocations

2 secondary outcomes

Evaluation of Pain and Functional Performance Determined by the Harris Hip Score
Time frame: 3 years postoperatively, due to early study termination
Confirmation of Safety Based on Complications
Time frame: 3 years postoperatively, due to early study termination

Results and safety

Results posted to the registry on 30 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Who Received the Stafit Acetabular System	166	0

Primary outcome: Implant Survival

Time frame: 3 years postoperatively, due to early study termination. Number. Unit: percentage of implant survival

Measure	Patients Who Received the Stafit Acetabular System n = 80
Value	100

Population analysed: Outcome Measure Data at 3 years postoperative (Study early terminated). The Kaplan-Meier survival rate with cup revision for any reason.

Primary outcome: Dislocation Rate

Time frame: 2 years. Number. Unit: Implant Dislocations

Measure	Patients Who Received the Stafit Acetabular System n = 161
Value	0

Population analysed: Count of the number of dislocations 2 years postoperatively.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Who Received the Stafit Acetabular System	10 of 166 (6%)	11 of 166 (6.6%)	6 of 166

Limitations and caveats (from the sponsor): Early study termination leading less patients enrolled and shorter follow-up as initially planned in the study protocol.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis, Hip

Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
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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.

Paola Vivoda study director

Zimmer Biomet

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis, Hip and Fracture of Hip, run by Zimmer Biomet.

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 3 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: stopped early, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

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 30 Jun 2020). 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?

Implant Survival (time frame: 3 years postoperatively, due to early study termination). The study lists 2 primary outcomes in all. 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 NCT04079114.

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 30 Jun 2020.