Joint DiseaseNCT03576573
Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components
An observational study of Joint Disease, run by MicroPort Orthopedics Inc. at 1 site in Germany.
Trial summary
MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Joint Disease
- What is being tested?
- PROCOTYL® C
- Type of treatment
- Medical device
- How many people
- 143 participants
- Where
- 1 siteGermany
- Study dates
- 27 Mar 2019to Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Subjects previously implanted with any MicroPort Orthopedics or Wright Medical Technology Femoral Stems and PROCOTYL® C Acetabular Components
Who may be able to join
- To be included in the study, subjects must meet all of the following criteria:
- Has previously undergone primary Total Hip Arthroscopy for any of the following:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;
- Inflammatory degenerative joint disease such as rheumatoid arthritis;
- Correction of functional deformity
- Subject was implanted with the specified combination of components, namely, any MicroPort Orthopedics or Wright Medical Technology femoral stem and PROCOTYL C Acetabular Components
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- Subject is willing and able to complete required study visits or assessments
- Previously implanted bilateral subjects can have both THAs (Total Hip Arthroscopy) enrolled in the study provided:
- the specified combination of components were implanted in both,
- all other aspects of the Inclusion/Exclusion Criteria are satisfied,
- enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and
- the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrolment of a previously unimplanted hip is not permitted in this study.
Who cannot join
- Subjects will be excluded if they meet any of the following criteria:
- Subject was skeletally immature (less than 21 years of age) at time of implantation
- Subject has a non-MicroPort or non-Wright Medical Technology component implanted (femoral heads, acetabular shells, acetabular liners) in the enrolled Total Hip Arthroscopy
- Subject is currently enrolled in another clinical investigation which could affect the endpoints of this protocol
- Subject is unwilling or unable to sign the Informed Consent document
- Subject has documented substance abuse issues
- Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
- Subject is currently incarcerated or has impending incarceration
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in Europe. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.
- Conditions
- Joint Disease
- Being tested
- PROCOTYL® C
- Keywords
- Osteoarthritis, Avascular necrosis, Ankylosis, Protrusio acetabuli, Painful hip dysplasia, Rheumatoid arthritis, Correction of functional deformity
- Medical subject headings
- Joint Diseases, Osteoarthritis, Osteonecrosis, Ankylosis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROCOTYL® CDevice
Also called Primary Total Hip Device
Hip Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Primary Total Hip Arthroplasty | Single arm study of subjects previously implanted with any MicroPort Orthopedics or Wright Medical Technology femoral stems and PROCOTYL® C Acetabular Components Receives: Device: PROCOTYL® C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Component Survivorship
The primary endpoint is to evaluate component survivorship of the PROCOTYL® C Acetabular Components out to 10 years follow-up. Percentage of hips survived with no revision or replacement at 10-year.
Measured: 10 years post-operative
Secondary outcomes (3)
To determine the cumulative incidence of component revision at specified intervals out to 10 years follow-up;
Percentage of hips that were revised or replaced at each of the intervals namely for Early (2-5 years), midterm (5-7 Year), and long-term (10-year) evaluation.
Measured: 2-5 years, 5-7 years, and 10 years
To characterize functional scores, as assessed by Oxford Hip.
The study will be reporting the final Oxford Hip score, which is a summary over 12 items. Each of these items is 5-level Likert scale such as from 'not at all' to 'totally'.
Measured: 2-5 years, 5-7 years, and 10 years
To characterize functional scores, as assessed by EQ-5D-3L scores.
EQ-5D-3L data will be summarized over 5 domains, namely, mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain has 3 levels: no problems, some problems, and extreme problems.
Measured: 2-5 years, 5-7 years, and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start27 Mar 2019
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MicroPort Orthopedics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576573
- Sponsor's protocol ID
- 12-LJH-002N
- Status last verified
- Nov 2023
- First submitted
- 26 Jun 2018
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components
- ClinicalTrials.gov ID
- NCT03576573
- Acronym / sponsor ID
- 12-LJH-002N
- Conditions
- Joint Disease
- Keywords
- Osteoarthritis, Avascular necrosis, Ankylosis, Protrusio acetabuli, Painful hip dysplasia, Rheumatoid arthritis, Correction of functional deformity
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- MicroPort Orthopedics Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 3 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in Europe. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Total Hip Arthroplasty | – | Device: PROCOTYL® CSingle arm study of subjects previously implanted with any MicroPort Orthopedics or Wright Medical Technology femoral stems and PROCOTYL® C Acetabular Components |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects previously implanted with any MicroPort Orthopedics or Wright Medical Technology Femoral Stems and PROCOTYL® C Acetabular Components
Key inclusion criteria (12 listed)
- Has previously undergone primary Total Hip Arthroscopy for any of the following:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;
- Inflammatory degenerative joint disease such as rheumatoid arthritis;
- Correction of functional deformity
- Subject was implanted with the specified combination of components, namely, any MicroPort Orthopedics or Wright Medical Technology femoral stem and PROCOTYL C Acetabular Components
Key exclusion criteria (8 listed)
- Subject was skeletally immature (less than 21 years of age) at time of implantation
- Subject has a non-MicroPort or non-Wright Medical Technology component implanted (femoral heads, acetabular shells, acetabular liners) in the enrolled Total Hip Arthroscopy
- Subject is currently enrolled in another clinical investigation which could affect the endpoints of this protocol
- Subject is unwilling or unable to sign the Informed Consent document
- Subject has documented substance abuse issues
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 |
|---|---|---|
| PROCOTYL® CAlso: Primary Total Hip DeviceHip Arthroplasty | Device | Primary Total Hip Arthroplasty |
Primary outcome
Component Survivorship
Time frame: 10 years post-operative
The primary endpoint is to evaluate component survivorship of the PROCOTYL® C Acetabular Components out to 10 years follow-up. Percentage of hips survived with no revision or replacement at 10-year.
3 secondary outcomes
To determine the cumulative incidence of component revision at specified intervals out to 10 years follow-up;
Time frame: 2-5 years, 5-7 years, and 10 years
To characterize functional scores, as assessed by Oxford Hip.
Time frame: 2-5 years, 5-7 years, and 10 years
To characterize functional scores, as assessed by EQ-5D-3L scores.
Time frame: 2-5 years, 5-7 years, and 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Disease, run by MicroPort Orthopedics Inc. at 1 site in Germany.
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 12 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
This study is still under way. Results are not available in the source record yet.
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?
Component Survivorship (time frame: 10 years post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2023.