Total Hip ReplacementNCT04277416
Survivorship and Effectiveness of the Ortho Development® Entrada™ Hip System for Total Hip Arthroplasty
An observational study of Total Hip Replacement and Total Hip Arthroplasty, run by Ortho Development Corporation at 1 site in United States.
Trial summary
To evaluate Implant survival based on removal or intended removal of any component of the Entrada™ Hip System at five years of follow-up. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Hip Replacement, Total Hip Arthroplasty
- What is being tested?
- Total Hip Arthroplasty
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2020to 31 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All orthopaedic patients that are scheduled to undergo primary total hip arthroplasty using the Entrada™ Hip System within 12 weeks will be screened for the following eligibility criteria.
Who may be able to join
- 1. Scheduled to undergo primary total hip arthroplasty using the Entrada™ Hip 2. System due to at least one of the following indications:
- Osteoarthritis
- Inflammatory arthropathy (Rheumatoid Arthritis, Psoriatic Arthritis, etc.) with sufficient bone stock for standard primary THA implants
- Avascular Necrosis with sufficient bone stock for standard primary THA implants
- Post-traumatic Arthritis
- Secondary arthritis due to congenital hip dysplasia 3. Willing and able to provide written informed consent for participation in the study.
- 4. Aged 18 - 80 years. 5. Able (in the Investigators opinion) and willing to comply with all study requirements and complete all study visits
Who cannot join
- The potential participant should be excluded from enrollment if any of the following exist:
- Body mass index ≥ 40
- History of other orthopaedic surgery within 6 months prior to the index surgery that, in the investigator's opinion, could affect the recovery of the index THA
- History of pyogenic arthritis in the surgical hip joint
- Active or suspected infection in or around the surgical hip joint
- A neurological disorder that, in the investigator's opinion, could affect lower extremity function and recovery from the index THA
Show all 10Show fewer
- The potential participant is incarcerated
- Prior fusion to the index surgical hip joint
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- 9 . Any other contraindication to THA listed in the Entrada™ Hip Stem Labelling or Instructions for Use.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Oregon Health Sciences University
Portland, Oregon, 97239
About this study
Official title: Survivorship and Effectiveness of the Ortho Development® Entrada™ Hip System for Total Hip Arthroplasty: A Prospective Multi-Centre Cohort Study
To evaluate Implant survival based on removal or intended removal of any component of the Entrada™ Hip System at five years of follow-up.
Read the detailed description
The purpose of this study is to provide clinical evidence for the safety and effectiveness of Ortho Development® Corporation's Entrada™ Hip System (Figure 1). The Entrada™ Hip System was fully introduced to the US market in July, 2018. The Entrada™ Hip System includes the Entrada™ Hip Stem, an FDA approved (510(K) # K171249) femoral stem coupled with either a cobalt chrome or Biolox® Delta Ceramic femoral head. Additionally, the stem and head are coupled with either the Escalade® or Legend® acetabular shell, both of which utilize highly cross-linked polyethylene liners.
- Conditions
- Total Hip Replacement, Total Hip Arthroplasty
- Being tested
- Total Hip Arthroplasty
- Keywords
- Ortho Development, Entrada Hip System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyDevice
To evaluate Implant survival based on removal or intended removal of any component of the Entrada™ Hip System at five years of follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Entrada Hip System | All orthopaedic patients that are scheduled to undergo primary total hip arthroplasty using the Entrada™ Hip System within 12 weeks will be screened for the following eligibility criteria. Receives: Device: Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survival
Implant survival based on removal or intended removal of any component of Entrada Hip Sys @five years follow-up. Will be measured using the Hip Disability and Osteoarthritis Outcome Score for Joint Reconstruction, the Patient-Reported Outcomes Measurement Information System Global Health Assessment, the UCLA Activity Rating Scale. Effectiveness will be assessed by achieving minimal clinically important difference (MCID) in HOOS JR and UCLA Activity scores. Hung et al. recently reported MCID of HOOS JR to be 19.68 units in an adult recon pop. The MCID for UCLA activity score has been reported to be 0.92 units.minimal detectable change for the PROMIS Global physical and mental health measures will be assessed using one-half of the standard dev between the pre and last post change score. MCID for numeric pain scale will be assessed as a 2 unit change in pain. HOOS, JR score ranges from 1-100 where 0 = total hip disability 100 = perfect hip health.
Measured: 5 - 10-year follow-up
Secondary outcomes (8)
Implant Survival
Implant survival based on removal or intended removal of any component of the Entrada™ Hip System at two and ten years of follow-up. Will be measured using the Hip Disability and Osteoarthritis Outcome Score for Joint Reconstruction (HOOS JR), the PROMIS Global Health Assessment (Physical health, mental health and Numeric pain score), and the UCLA Activity Rating Scale.
Measured: 2 - 10 year follow-up
Hip Disability and Osteoarthritis Outcome Score for Joint Reconstruction (HOOS JR)
The HOOS JR patient reported outcome instrument will be assessed at one, two, five and ten years. The HOOS JR measures function and pain in the involved hip.
Measured: 2 - 10-year follow-up
PROMIS Global Health Assessment (Physical health, mental health and numeric pain score)
The PROMIS Global 10 patient reported outcome instrument will be assessed at one, two, five and ten years. The PROMIS Global 10 measures physical health, mental health and provides an 11 point numeric pain score.
Measured: 2 - 10-year follow-up
UCLA Activity Rating Scale
The UCLA patient reported outcome instrument will be assessed at one, two, five and ten years. The scale is from 1 - 10 with higher values indicating greater physical function.
Measured: 2 - 10-year follow-up
Patient Satisfaction
Patient Satisfaction with their hip replacement will be assessed at one, two, five and ten years. Satisfaction will be measured on a 5 point likert scale from very unsatisfied to very satisfied.
Measured: 2 - 10-year follow-up
Radiographic Outcomes
Radiographic adverse events: Adverse events will be captured on the adverse event case report form. Radiographic adverse events will be evaluated using the zones for radiolucencies as described on the radiographic evaluation case report form. These include the femoral zones described by Gruen et al. Radiolucent lines <2mm will be considered fibrous integration as per the review of Vanrusselt et al. Without evidence of progression these lines will not be considered evidence of aseptic loosening.
Measured: 2 - 10-year follow-up
Clinical Outcomes
Clinical adverse events: Adverse events will be captured on the adverse event case report form.
Measured: 2 - 10-year follow-up
Patient Satisfaction
Satisfaction with the surgical intervention according to the PROMIS Global 10 methods of Rolfson et al.
Measured: 2 - 10-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start28 Feb 2020
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ReplacementStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ortho Development Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oregon Health and Science University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277416
- Sponsor's protocol ID
- P-19-0055
- Status last verified
- Oct 2022
- First submitted
- 6 Nov 2019
- Last updated
- 13 Oct 2022
- 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 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivorship and Effectiveness of the Ortho Development® Entrada™ Hip System for Total Hip Arthroplasty: A Prospective Multi-Centre Cohort Study
- ClinicalTrials.gov ID
- NCT04277416
- Acronym / sponsor ID
- P-19-0055
- Conditions
- Total Hip Replacement, Total Hip Arthroplasty
- Keywords
- Ortho Development, Entrada Hip System
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ortho Development CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Oregon Health and Science University
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 20 Feb 2020 (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.
To evaluate Implant survival based on removal or intended removal of any component of the Entrada™ Hip System at five years of follow-up.
Detailed description
The purpose of this study is to provide clinical evidence for the safety and effectiveness of Ortho Development® Corporation's Entrada™ Hip System (Figure 1). The Entrada™ Hip System was fully introduced to the US market in July, 2018. The Entrada™ Hip System includes the Entrada™ Hip Stem, an FDA approved (510(K) # K171249) femoral stem coupled with either a cobalt chrome or Biolox® Delta Ceramic femoral head. Additionally, the stem and head are coupled with either the Escalade® or Legend® acetabular shell, both of which utilize highly cross-linked polyethylene liners.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Entrada Hip System | – | Device: Total Hip ArthroplastyAll orthopaedic patients that are scheduled to undergo primary total hip arthroplasty using the Entrada™ Hip System within 12 weeks will be screened for the following eligibility criteria. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All orthopaedic patients that are scheduled to undergo primary total hip arthroplasty using the Entrada™ Hip System within 12 weeks will be screened for the following eligibility criteria.
Key inclusion criteria (7 listed)
- 1. Scheduled to undergo primary total hip arthroplasty using the Entrada™ Hip 2. System due to at least one of the following indications:
- Osteoarthritis
- Inflammatory arthropathy (Rheumatoid Arthritis, Psoriatic Arthritis, etc.) with sufficient bone stock for standard primary THA implants
- Avascular Necrosis with sufficient bone stock for standard primary THA implants
- Post-traumatic Arthritis
Key exclusion criteria (10 listed)
- The potential participant should be excluded from enrollment if any of the following exist:
- Body mass index ≥ 40
- History of other orthopaedic surgery within 6 months prior to the index surgery that, in the investigator's opinion, could affect the recovery of the index THA
- History of pyogenic arthritis in the surgical hip joint
- Active or suspected infection in or around the surgical hip joint
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 ArthroplastyTo evaluate Implant survival based on removal or intended removal of any component of the Entrada™ Hip System at five years of follow-up. | Device | Entrada Hip System |
Primary outcome
Implant Survival
Time frame: 5 - 10-year follow-up
Implant survival based on removal or intended removal of any component of Entrada Hip Sys @five years follow-up. Will be measured using the Hip Disability and Osteoarthritis Outcome Score for Joint Reconstruction, the Patient-Reported Outcomes Measurement Information System Global Health Assessment, the UCLA Activity Rating Scale. Effectiveness will be assessed by achieving minimal clinically important difference (MCID) in HOOS JR and UCLA Activity scores. Hung et al. recently reported MCID of HOOS JR to be 19.68 units in an adult recon pop. The MCID for UCLA activity score has been reported to be 0.92 units.minimal detectable change for the PROMIS Global physical and mental health measures will be assessed using one-half of the standard dev between the pre and last post change score. MCID for numeric pain scale will be assessed as a 2 unit change in pain. HOOS, JR score ranges from 1-100 where 0 = total hip disability 100 = perfect hip health.
8 secondary outcomes
Implant Survival
Time frame: 2 - 10 year follow-up
Hip Disability and Osteoarthritis Outcome Score for Joint Reconstruction (HOOS JR)
Time frame: 2 - 10-year follow-up
PROMIS Global Health Assessment (Physical health, mental health and numeric pain score)
Time frame: 2 - 10-year follow-up
UCLA Activity Rating Scale
Time frame: 2 - 10-year follow-up
Patient Satisfaction
Time frame: 2 - 10-year follow-up
Radiographic Outcomes
Time frame: 2 - 10-year follow-up
Clinical Outcomes
Time frame: 2 - 10-year follow-up
Patient Satisfaction
Time frame: 2 - 10-year follow-up
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 13 Oct 2022.
- 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 Total Hip Replacement and Total Hip Arthroplasty, run by Ortho Development Corporation 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 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: enrolling by invitation, as of the sponsor's last update on 13 Oct 2022. 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?
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?
Implant Survival (time frame: 5 - 10-year follow-up). 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 13 Oct 2022.