Arthroplasty, Replacement, HipPALNCT01312428
Pelvic Alignment Level (PAL) Instrument Evaluation
A study testing Pelvic Alignment Level (PAL) Instrument and No Pelvic Alignment Level (PAL) Instrument in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 1 site in United States.
Trial summary
The study is conducted to evaluate the performance of the Pelvic Alignment Level (PAL) instrument in achieving desired acetabular position, desired leg length and offset after Total Hip Replacement (THR) reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Pelvic Alignment Level (PAL) Instrument and No Pelvic Alignment Level (PAL) Instrument
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Apr 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has signed an IRB approved, evaluation specific Informed Patient Consent Form.
- Patient is a male or non-pregnant female age 18 years or older at time of enrollment.
- Patient clinically qualifies for total hip arthroplastic surgery, based on physical examination and medical history.
- Patient must have a diagnosis of: osteoarthritis, traumatic arthritis, avascular necrosis, slipped capital epiphysis, pelvic fracture, failed fracture fixation or rheumatoid arthritis.
Who cannot join
- Patient's anatomy precludes a cup placement of 45° inclination and 20° anteversion.
- Patient has an active infection within the affected hip joint.
- Patient is a prisoner.
- Patient has plans to relocate to another geographic area before the completion of the evaluation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthcare Center for Advanced Medicine
Louisville, Kentucky, 40202
About this study
Official title: A Prospective Clinical Evaluation of Acetabular Cup Placement in Total Hip Replacements Utilizing a Pelvic Alignment Level (PAL) Instrument
The study is conducted to evaluate the performance of the Pelvic Alignment Level (PAL) instrument in achieving desired acetabular position, desired leg length and offset after Total Hip Replacement (THR) reconstruction.
Read the detailed description
Total hip replacement (THR) has been a sucessful treatment for cases of degenerative joint diseases. However, post operative complications such as dislocations, osteolysis, component wear and migration are still a concern. It has been noted in the scientific literature that precise acetabular cup position helps reduce such post operative complications. The Pelvic Alignment Level (PAL) offers this solution by assessing pelvic motion and optimizing implant position without the need for intra-operative fluoroscopy or a large capital expenditure. The focus of this study is to evaluate the clinical outcomes (acetabular cup placement, femoral offset, and leg length) of using the PAL instrument to those without using PAL instrument during total hip replacement. This will be a prospective, post market, randomized multi-center clinical study.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- Pelvic Alignment Level (PAL) Instrument, No Pelvic Alignment Level (PAL) Instrument
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Alignment Level (PAL) InstrumentDevice
Pelvic Alignment Level Instrument Used
No Pelvic Alignment Level (PAL) InstrumentDevice
No Pelvic Alignment Level Instrument Used
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Alignment Level (PAL) | Other | Pelvic Alignment Level Instrument Used Receives: Device: Pelvic Alignment Level (PAL) Instrument |
| No Pelvic Alignment Level (PAL) | Other | No Pelvic Alignment Level Instrument Used Receives: Device: No Pelvic Alignment Level (PAL) Instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate the Surgical Accuracy in Placing Acetabular Components at a Target of 45° Inclination and 20° Anteversion While Using the PAL Compared to Surgeries Without Using the PAL Instrument.
Measured: 6 week follow-up
Secondary outcomes (1)
To Evaluate the Surgical Success of Achieving Preoperative Targets for Leg Length and Femoral Offset, or be Able to Document Changes to Pre-operative Leg Length and Offset, Using the PAL Compared to Surgeries Without Using the PAL Instrument.
Measured: 6 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Lagging enrollment
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 Arthroplasty, Replacement, HipStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arthur L. Malkani, MD, Study chair, Healthcare Center for Advanced Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312428
- Sponsor's protocol ID
- 64
- Acronym
- PAL
- Status last verified
- Feb 2015
- First submitted
- 8 Mar 2011
- Last updated
- 17 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Evaluation of Acetabular Cup Placement in Total Hip Replacements Utilizing a Pelvic Alignment Level (PAL) Instrument
- ClinicalTrials.gov ID
- NCT01312428
- Acronym / sponsor ID
- PAL / 64
- Conditions
- Arthroplasty, Replacement, Hip
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lagging enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 10 Mar 2011 (estimated)
- Results
- Posted 28 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is conducted to evaluate the performance of the Pelvic Alignment Level (PAL) instrument in achieving desired acetabular position, desired leg length and offset after Total Hip Replacement (THR) reconstruction.
Detailed description
Total hip replacement (THR) has been a sucessful treatment for cases of degenerative joint diseases. However, post operative complications such as dislocations, osteolysis, component wear and migration are still a concern. It has been noted in the scientific literature that precise acetabular cup position helps reduce such post operative complications. The Pelvic Alignment Level (PAL) offers this solution by assessing pelvic motion and optimizing implant position without the need for intra-operative fluoroscopy or a large capital expenditure. The focus of this study is to evaluate the clinical outcomes (acetabular cup placement, femoral offset, and leg length) of using the PAL instrument to those without using PAL instrument during total hip replacement. This will be a prospective, post market, randomized multi-center clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Alignment Level (PAL) | Other | Device: Pelvic Alignment Level (PAL) InstrumentPelvic Alignment Level Instrument Used |
| No Pelvic Alignment Level (PAL) | Other | Device: No Pelvic Alignment Level (PAL) InstrumentNo Pelvic Alignment Level Instrument Used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has signed an IRB approved, evaluation specific Informed Patient Consent Form.
- Patient is a male or non-pregnant female age 18 years or older at time of enrollment.
- Patient clinically qualifies for total hip arthroplastic surgery, based on physical examination and medical history.
- Patient must have a diagnosis of: osteoarthritis, traumatic arthritis, avascular necrosis, slipped capital epiphysis, pelvic fracture, failed fracture fixation or rheumatoid arthritis.
Key exclusion criteria (4 listed)
- Patient's anatomy precludes a cup placement of 45° inclination and 20° anteversion.
- Patient has an active infection within the affected hip joint.
- Patient is a prisoner.
- Patient has plans to relocate to another geographic area before the completion of the evaluation.
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 |
|---|---|---|
| Pelvic Alignment Level (PAL) InstrumentPelvic Alignment Level Instrument Used | Device | Pelvic Alignment Level (PAL) |
| No Pelvic Alignment Level (PAL) InstrumentNo Pelvic Alignment Level Instrument Used | Device | No Pelvic Alignment Level (PAL) |
Primary outcome
To Evaluate the Surgical Accuracy in Placing Acetabular Components at a Target of 45° Inclination and 20° Anteversion While Using the PAL Compared to Surgeries Without Using the PAL Instrument.
Time frame: 6 week follow-up
1 secondary outcome
To Evaluate the Surgical Success of Achieving Preoperative Targets for Leg Length and Femoral Offset, or be Able to Document Changes to Pre-operative Leg Length and Offset, Using the PAL Compared to Surgeries Without Using the PAL Instrument.
Time frame: 6 week follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Arthur L. Malkani, MD study chair
Healthcare Center for Advanced Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Alignment Level (PAL) Instrument and No Pelvic Alignment Level (PAL) Instrument in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics 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 4 inclusion and 4 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 17 Nov 2017. 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?
Yes. Results are posted in the registry (first posted 28 Aug 2014). 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?
To Evaluate the Surgical Accuracy in Placing Acetabular Components at a Target of 45° Inclination and 20° Anteversion While Using the PAL Compared to Surgeries Without Using the PAL Instrument. (time frame: 6 week 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 17 Nov 2017.