Noninflammatory Degenerative Joint DiseaseNCT02220478
Signature Acetabular Posterior/Lateral Data Collection
A study testing Posterior Lateral Approach Total Hip Arthroplasty in people with Noninflammatory Degenerative Joint Disease and Avascular Necrosis, run by Zimmer Biomet.
Trial summary
The primary purpose of this pilot study is to evaluate the accuracy of cup placement between two instrumentation technologies: Cutting Guide and Conventional Instrumentation. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Noninflammatory Degenerative Joint Disease, Avascular Necrosis, Rheumatoid Arthritis
- What is being tested?
- Posterior Lateral Approach Total Hip Arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jul 2016
- Phase
- Interventional
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with one of the following indication:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- Additional inclusion criteria include:
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- Subjects requiring primary total hip arthroplasty
- 20 to 75 years of age
- Subjects with a diagnosis of osteoarthritis or traumatic arthritis
- Subjects willing to return for follow-up evaluations.
- Subjects who can read, understand study information and give written consent without representation of a legally authorized representative.
- Bilateral patients are included if staged.
- Only Posterior Lateral Approach can be used for inclusion in this study
Who cannot join
- Exclusion criteria should be in accordance with Contraindications for the Biomet primary acetabular cup.
- Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement.
- Additional contraindications include:
- Subjects whose bony structure deviates substantially from the general norm sufficiently to require non-standard implants. Specific examples of these are total dislocation of the hip, severe coxa vera deformity, and severe forms of multiple epiphyseal dysplasia
- Subjects unable to cooperate with and complete the study
- Dementia and inability to understand and follow instructions
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- Neurological conditions affecting movement
- Pregnancy
- Additional exclusion criteria include:
- Surgical approach other than posterior lateral.
- Simultaneous bilateral procedures
About this study
Official title: A Prospective Controlled Study on Signature Anterior Posterior/Lateral Acetabular Cup Placement System in Total Hip Arthroplasty
The primary purpose of this pilot study is to evaluate the accuracy of cup placement between two instrumentation technologies: Cutting Guide and Conventional Instrumentation.
Read the detailed description
Using a more advanced surgical technique may assist surgeons and patients in a variety of ways including identifying a specific-size for the prosthesis prior to surgery, increasing operating room efficiency, and reducing the number of traditional instruments needed. This may reduce cost associated with the instrument inventory and instrument sterilization. Operating time may also be reduced, potentially decreasing the patient's risk of infection. However, before these hypotheses can be tested, it is important to fully understand the efficacy and accuracy of Signature Custom Guides and their use in Total Hip Arthroplasty.
- Being tested
- Posterior Lateral Approach Total Hip Arthroplasty
- Keywords
- hip, Signature
- Medical subject headings
- Osteonecrosis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Lateral Approach Total Hip ArthroplastyDevice
All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.
| Study group | Role | What they receive |
|---|---|---|
| Signature Cutting Guides | Active comparator | Patients indicated for a Posterior Lateral THA utilizing non implantable Signature Cutting Guides during surgery. Receives: Device: Posterior Lateral Approach Total Hip Arthroplasty |
| Conventional Instrumentation | Active comparator | Patients indicated for a Posterior Lateral THA utilizing non implantable Conventional Instrumentation during surgery. Receives: Device: Posterior Lateral Approach Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Room Time
Average operative time
Measured: Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startNov 2014
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Unable to engage surgeons to participate in the study
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 Noninflammatory Degenerative Joint DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Russell Schenck, Ph.D., Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220478
- Sponsor's protocol ID
- ORTHO.CR.GH24
- Status last verified
- Sep 2022
- First submitted
- 18 Aug 2014
- Last updated
- 25 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Controlled Study on Signature Anterior Posterior/Lateral Acetabular Cup Placement System in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02220478
- Acronym / sponsor ID
- ORTHO.CR.GH24
- Keywords
- hip, Signature
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to engage surgeons to participate in the study
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Posted 25 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this pilot study is to evaluate the accuracy of cup placement between two instrumentation technologies: Cutting Guide and Conventional Instrumentation.
Detailed description
Using a more advanced surgical technique may assist surgeons and patients in a variety of ways including identifying a specific-size for the prosthesis prior to surgery, increasing operating room efficiency, and reducing the number of traditional instruments needed. This may reduce cost associated with the instrument inventory and instrument sterilization. Operating time may also be reduced, potentially decreasing the patient's risk of infection. However, before these hypotheses can be tested, it is important to fully understand the efficacy and accuracy of Signature Custom Guides and their use in Total Hip Arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Signature Cutting Guides | Active comparator | Device: Posterior Lateral Approach Total Hip ArthroplastyPatients indicated for a Posterior Lateral THA utilizing non implantable Signature Cutting Guides during surgery. |
| Conventional Instrumentation | Active comparator | Device: Posterior Lateral Approach Total Hip ArthroplastyPatients indicated for a Posterior Lateral THA utilizing non implantable Conventional Instrumentation during surgery. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects with one of the following indication:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
Key exclusion criteria (11 listed)
- Exclusion criteria should be in accordance with Contraindications for the Biomet primary acetabular cup.
- Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement.
- Subjects whose bony structure deviates substantially from the general norm sufficiently to require non-standard implants. Specific examples of these are total dislocation of the hip, severe coxa vera deformity, and severe forms of multiple epiphyseal dysplasia
- Subjects unable to cooperate with and complete the study
- Dementia and inability to understand and follow instructions
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 |
|---|---|---|
| Posterior Lateral Approach Total Hip ArthroplastyAll patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach. | Device | Conventional Instrumentation, Signature Cutting Guides |
Primary outcome
Operative Room Time
Time frame: Surgery
Average operative time
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Russell Schenck, Ph.D. study director
Zimmer Biomet
Questions about this trial
What is this clinical trial studying?
A study testing Posterior Lateral Approach Total Hip Arthroplasty in people with Noninflammatory Degenerative Joint Disease and Avascular Necrosis, 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 13 inclusion and 11 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 25 Oct 2022. 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 25 Oct 2022). 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?
Operative Room Time (time frame: Surgery). 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 25 Oct 2022.