Non-inflammatory Degenerative Joint Disease (NIDJD)NCT05980234
MDR - Longevity IT Oblique and Offset Liners
An observational study of Non-inflammatory Degenerative Joint Disease (NIDJD) and Avascular Necrosis, run by Zimmer Biomet at 1 site in United States.
Trial summary
The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Longevity IT Oblique and Offset liners when used for primary or revision total hip arthroplasty (implants and instrumentation) at a minimum… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-inflammatory Degenerative Joint Disease (NIDJD), Avascular Necrosis, Protrusio Acetabuli
- What is being tested?
- Total Hip Arthroplasty with Longevity IT Oblique Liners and Total Hip Arthroplasty with Longevity IT Offset Liners
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2023to 7 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: The study population should be a consecutive series of subjects implanted with the Longevity IT Oblique and/or Offset liners in either primary or revision THA. Up to 52 implanted hips with the Oblique liners and up to 52 implanted hips with the Offset liners will be included in the study. The study population for primary statistical analysis will be comprised of males and females who satisfy the inclusion/exclusion criteria outlined in the protocol. To avoid potential selection bias, each Investigator will offer study participation to each consecutive eligible patient presenting as a potential candidate. Eligible candidates who express interest in study participation will be offered Informed Consent.
Who may be able to join
- Study devices must have been implanted following the appropriate surgical technique and IFU
- Patient must be 18 years of age or older
- Patient must be willing and able to sign or verbally consent using the IRB approved informed consent
- Patient must have undergone primary or revision hip arthroplasty with the Longevity IT Oblique and/or Offset liners according to a cleared indication, which includes the following:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital, epiphysis, fused hip, fracture of the pelvis, and diastrophic variant
- Revision where other devices or treatments have failed
- Patient must have reached full skeletal maturity
Who cannot join
- Off-label use of study devices
- Osteoradionecrosis
- Neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation
- Systemic or local infection
- Uncooperative patient or patient with neurologic disorders who is incapable of following directions
- Patient is known to be pregnant or nursing
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- Patient is a prisoner
- Patient is a known alcohol or drug abuser
- Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PMCF Study to Provide Safety, Performance, and Clinical Benefits Data of the Longevity IT Oblique and Offset Liners in Primary and Revision Total Hip Arthroplasty - A Retrospective Enrollment/Prospective Follow-up Consecutive Series Study
The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Longevity IT Oblique and Offset liners when used for primary or revision total hip arthroplasty (implants and instrumentation) at a minimum of 10-year follow-up.
Read the detailed description
The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Longevity IT Oblique and Offset liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 1, 3, 5, 7, and 10 years*. The subject devices have been on the market since 2010 but have insufficient data to support 10 years of clinical history. A prospective aspect to the study will be utilized to collect long-term data.
- Conditions
- Non-inflammatory Degenerative Joint Disease (NIDJD), Avascular Necrosis, Protrusio Acetabuli, Traumatic Arthritis, Slipped Capital Femoral Epiphyses, Fracture of the Pelvis
- Being tested
- Total Hip Arthroplasty with Longevity IT Oblique Liners, Total Hip Arthroplasty with Longevity IT Offset Liners
- Medical subject headings
- Osteonecrosis, Slipped Capital Femoral Epiphyses, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip Arthroplasty with Longevity IT Oblique LinersDevice
Primary or Revision Total Hip Arthroplasty using the Longevity IT Oblique liners according to the approved indications and compatible device.
Total Hip Arthroplasty with Longevity IT Offset LinersDevice
Primary or Revision Total Hip Arthroplasty using the Longevity IT Offset liners according to the approved indications and compatible device.
| Study group | Role | What they receive |
|---|---|---|
| Longevity IT Oblique Liners | The Longevity IT Oblique liner was designed to provide variable joint anteversion and abduction. Receives: Device: Total Hip Arthroplasty with Longevity IT Oblique Liners | |
| Longevity IT Offset Liners | The Longevity IT Offset liner was designed to lateralize the center of rotation of the cup. Receives: Device: Total Hip Arthroplasty with Longevity IT Offset Liners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent Adverse Events (safety)
This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events with particular focus on those that may be related to the study device.
Measured: 10 years
Secondary outcomes (3)
Pain and Functional Performance - Oxford Hip Score
"The Oxford Hip Score is patient-reported outcome instrument which contains 12 questions on activities of daily living that assess function and residual pain in patients undergoing total hip replacement surgery.
Grading the Oxford Hip Score 0 to 19-May indicate severe hip arthritis... 20 to 29-May indicate moderate to severe hip arthritis... 30 to 39-May indicate mild to moderate hip arthritis... 40 to 48-May indicate satisfactory joint function..." Oxford Hip Score. (n.d.) Segen's Medical Dictionary. (2011). Retrieved August 19 2022 from https://medical-dictionary.thefreedictionary.com/Oxford+Hip+Score
Measured: 10 years
Performance and Clinical Benefits - Harris Hip Score
Patient Assessment: reported Harris Hip Score (if available)
Harris Hip Score:
The HHS is divided into three sections. The first section questions is about pain and its impact, which are answered by the patient or client. The second and third sections require the physiotherapist to assess the patient or client's hip joint and function.
The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
Measured: 10 years
Performance and Clinical Benefits - Activity Level
Patient Assessment: activity level
Records patient's activity level on a 10-point scale from 'wholly inactive' to 'regularly particpates in impact sports.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start30 Aug 2023
- Primary completion2 Nov 2024
- Study completion7 Nov 2024
Why it stopped: Zimmer Biomet received the CE mark for the Continuum and Trilogy IT Acetabular System, which includes the Longevity IT Offset and Oblique Liners, in June 2024.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-inflammatory Degenerative Joint Disease (NIDJD)Studies 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
- Other
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hillary Overholser, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980234
- Sponsor's protocol ID
- MDRG2017-89MS-107H
- Status last verified
- Dec 2024
- First submitted
- 24 Jul 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PMCF Study to Provide Safety, Performance, and Clinical Benefits Data of the Longevity IT Oblique and Offset Liners in Primary and Revision Total Hip Arthroplasty - A Retrospective Enrollment/Prospective Follow-up Consecutive Series Study
- ClinicalTrials.gov ID
- NCT05980234
- Acronym / sponsor ID
- MDRG2017-89MS-107H
- Conditions
- Non-inflammatory Degenerative Joint Disease (NIDJD), Avascular Necrosis, Protrusio Acetabuli, Traumatic Arthritis, Slipped Capital Femoral Epiphyses, Fracture of the Pelvis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Zimmer Biomet received the CE mark for the Continuum and Trilogy IT Acetabular System, which includes the Longevity IT Offset and Oblique Liners, in June 2024.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 2 Nov 2024 (actual)
- Study completion
- 7 Nov 2024 (actual)
- First posted
- 7 Aug 2023 (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.
The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Longevity IT Oblique and Offset liners when used for primary or revision total hip arthroplasty (implants and instrumentation) at a minimum of 10-year follow-up.
Detailed description
The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Longevity IT Oblique and Offset liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 1, 3, 5, 7, and 10 years*. The subject devices have been on the market since 2010 but have insufficient data to support 10 years of clinical history. A prospective aspect to the study will be utilized to collect long-term data.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Longevity IT Oblique Liners | – | Device: Total Hip Arthroplasty with Longevity IT Oblique LinersThe Longevity IT Oblique liner was designed to provide variable joint anteversion and abduction. |
| Longevity IT Offset Liners | – | Device: Total Hip Arthroplasty with Longevity IT Offset LinersThe Longevity IT Offset liner was designed to lateralize the center of rotation of the cup. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population should be a consecutive series of subjects implanted with the Longevity IT Oblique and/or Offset liners in either primary or revision THA. Up to 52 implanted hips with the Oblique liners and up to 52 implanted hips with the Offset liners will be included in the study. The study population for primary statistical analysis will be comprised of males and females who satisfy the inclusion/exclusion criteria outlined in the protocol. To avoid potential selection bias, each Investigator will offer study participation to each consecutive eligible patient presenting as a potential candidate. Eligible candidates who express interest in study participation will be offered Informed Consent.
Key inclusion criteria (7 listed)
- Study devices must have been implanted following the appropriate surgical technique and IFU
- Patient must be 18 years of age or older
- Patient must be willing and able to sign or verbally consent using the IRB approved informed consent
- Patient must have undergone primary or revision hip arthroplasty with the Longevity IT Oblique and/or Offset liners according to a cleared indication, which includes the following:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital, epiphysis, fused hip, fracture of the pelvis, and diastrophic variant
Key exclusion criteria (9 listed)
- Off-label use of study devices
- Osteoradionecrosis
- Neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation
- Systemic or local infection
- Uncooperative patient or patient with neurologic disorders who is incapable of following directions
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 with Longevity IT Oblique LinersPrimary or Revision Total Hip Arthroplasty using the Longevity IT Oblique liners according to the approved indications and compatible device. | Device | Longevity IT Oblique Liners |
| Total Hip Arthroplasty with Longevity IT Offset LinersPrimary or Revision Total Hip Arthroplasty using the Longevity IT Offset liners according to the approved indications and compatible device. | Device | Longevity IT Offset Liners |
Primary outcome
Incidence of treatment-emergent Adverse Events (safety)
Time frame: 10 years
This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events with particular focus on those that may be related to the study device.
3 secondary outcomes
Pain and Functional Performance - Oxford Hip Score
Time frame: 10 years
Performance and Clinical Benefits - Harris Hip Score
Time frame: 10 years
Performance and Clinical Benefits - Activity Level
Time frame: 10 years
Results and safety
The study was stopped early (reason given: Zimmer Biomet received the CE mark for the Continuum and Trilogy IT Acetabular System, which includes the Longevity IT Offset and Oblique Liners, in June 2024.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- 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. This study is not recruiting at the moment.
Hillary Overholser study director
Zimmer Biomet
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 Non-inflammatory Degenerative Joint Disease (NIDJD) and Avascular Necrosis, run by Zimmer Biomet at 1 site in United States.
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 7 inclusion and 9 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 27 Dec 2024. 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 United States. 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?
The study was stopped early (reason given: Zimmer Biomet received the CE mark for the Continuum and Trilogy IT Acetabular System, which includes the Longevity IT Offset and Oblique Liners, in June 2024.). Results are not available in the source record.
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?
Incidence of treatment-emergent Adverse Events (safety) (time frame: 10 years). 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 27 Dec 2024.