ArthritisNCT02204007
Real Time 3D Imaging and Surrogate Bone Model
A study testing 3D imaging & surrogate bone model in people with Arthritis, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This is an observer-blinded prospective randomized clinical trial to define the efficacy of a new technology developed at the Cleveland Clinic to improve the positioning of the acetabular shell in total hip arthroplasty.The proposed study will enroll patients that have consented to total hip arthroplasty with or… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis
- What is being tested?
- 3D imaging & surrogate bone model
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jan 2015
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects to be included in this protocol will be adult males and females of all races and socioeconomic status meeting the following criteria:
- Primary, unilateral Total hip arthroplasty (THA)
- 18 to 85 years old at time of surgery
- Able to get a pre- and post-operative CT scan at the Cleveland Clinic Main Campus at least 10 days prior to surgery
Who cannot join
- Significant metal in the joint that results in metal artifact on the pre--operative CT scan, thereby compromising the ability to visualize the acetabulum on the pre-operative simulator.
- Pregnancy
- Incarceration
- Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Acetabular Shell Position Using 3D Planning vs. Standard Preoperative Planning: A Randomized Clinical Trial
This is an observer-blinded prospective randomized clinical trial to define the efficacy of a new technology developed at the Cleveland Clinic to improve the positioning of the acetabular shell in total hip arthroplasty.The proposed study will enroll patients that have consented to total hip arthroplasty with or without screw fixation for treatment of hip pathology. This treatment is standard of care. Patients will receive standard of care pre- and post-operative care and placement of standard of care implants all of which are commercially available and FDA approved for general use for the clinical indications used in these patients. The only difference in treatment between the groups will be the use of a surrogate bone model to help assist the surgeon visualize the ideal placement of the acetabular component. Diagnostic testing performed specifically related to this study consists of obtaining one pre-operative and one post-operative CT scan. The post-operative scan is to be performed within two weeks of surgery.
The investigators predict that those patients with 3D imaging and bone model will have better acetabular shell placement than those with standard preoperative planning.
Read the detailed description
The plan is enroll 44 subjects (22 in the standard surgery group and 22 in the experimental surgical group) into this randomized clinical trial. All subjects will have the standard of care indications for THA and will give informed consent for both the surgery and participation in this study. Enrollment will occur as part of the routine office evaluation and will be obtained by the treating surgeon or by the research assistant. Four surgeons (Wael Barsoum, Trevor Murray, Carlos Higuera, and Michael Bloomfield) with surgical experience in total hip arthroplasty will perform the procedures in this study. All subjects within each surgeon's practice who qualify for participation in this study will be approached. Subjects will be enrolled at least 10 days prior to the date of surgery. Ten days is the minimum time necessary to obtain a pre-operative CT scan for surgical planning and to manufacture the surrogate bone model. Patients who are not approached during regular office visits will be contacted by phone and if they are interested, they will be scheduled to arrive to the radiology department to sign the informed consent and receive the preoperative CT scan. Subjects will be randomized into either the experimental or control group at the time of consent by the study coordinator. Subjects in the experimental group will have their pre-operative planning done using the 3D surgical simulator and surrogate bone model will be available for the surgeon during surgery. Subjects in the control group will have their pre-operative planning done using plain film x-ray and two-dimensional (2D) templates.
Eligible subjects for inclusion in the study will be able to receive a pelvic CT scan at the Cleveland Clinic. Additionally, we will obtain standard of care pre- and post-operative x-rays (AP view). For subjects randomized into the experimental group, their CT scan DICOM images will be uploaded into the Cleveland Clinic developed surgical simulator specifically designed for THA at least 10 days prior to surgery. For each experimental subject, the Cleveland Clinic pre-operative planning software will be used to define the optimal size and location of the acetabular components (acetabular shell, and the ultra-high molecular weight polyethylene bearing - UHMWPE). The treating surgeon will virtually place the implant in the simulator software. The specification for shell placement will vary depending on the subject's individual pathology and pelvic morphology, but is expected to fall within the range of 10-35 degrees of anteversion and 30-50 degrees of abduction.
In the control group, each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays. To prepare the acetabulum and place the implants on the day of surgery, surgeons will use standard surgical alignment instruments provided by the manufacturer of the implant. For the experimental group, the surgeon will use CT scan and a 3D preoperative planning software to place the implants virtually. The surgeons are provided with a surrogate bone model with a fabricated acetabular implant placed in the same orientation as was planned in the surgical simulator software, and will use standard surgical instruments provided by the manufacturer of the implant.
The images obtained from the post-operative CT scans will be uploaded into the simulator software for 3D reconstruction. The 3D image of the post-operative pelvis with the implants will be superimposed onto the image of the pre-operative pelvis with the virtually placed implants. Using measurement tools within the software we will compare the position of the actual acetabular component placed in the patient with the desired position specified by the plan. The measurements that will be made are for angular orientations in 3D space (anteversion and inclination). Measurements are accurate to within a fraction of a degree.
- Conditions
- Arthritis
- Being tested
- 3D imaging & surrogate bone model
- Keywords
- Acetabular Shell, Total Hip Arthroplasty, 3D imaging
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D imaging & surrogate bone modelDevice
3D imaging \& surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging
| Study group | Role | What they receive |
|---|---|---|
| 3D imaging, surrogate bone model | Experimental | 3D imaging \& surrogate bone model Receives: Device: 3D imaging & surrogate bone model |
| Standard of Care Preoperative Imaging | No intervention | Patients receiving standard of care preoperative planning prior to total hip arthroplasty. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetabular Shell Version and Inclination
A CT scan of all patients will be obtained within 2 weeks of surgery to measure placement (acetabular version \& inclination measured in degrees) of the acetabular shell
Measured: within 2 weeks of surgery
Secondary outcomes (1)
Operative Time
Duration of the surgical case
Measured: time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Small number of subjects
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.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Higuera, MD, Principal investigator, The Cleveland ClinicAlison Klika, MS, Study director, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204007
- Sponsor's protocol ID
- 14-555
- Status last verified
- Feb 2017
- First submitted
- 28 Jul 2014
- Last updated
- 29 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Codsi MJ, Bennetts C, Gordiev K, Boeck DM, Kwon Y, Brems J, Powell K, Iannotti JP. Normal glenoid vault anatomy and validation of a novel glenoid implant shape. J Shoulder Elbow Surg. 2008 May-Jun;17(3):471-8. doi: 10.1016/j.jse.2007.08.010. Epub 2008 Mar 7.
PubMed 18328741Scalise JJ, Bryan J, Polster J, Brems JJ, Iannotti JP. Quantitative analysis of glenoid bone loss in osteoarthritis using three-dimensional computed tomography scans. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):328-35. doi: 10.1016/j.jse.2007.07.013. Epub 2008 Jan 22.
PubMed 18218326Scalise JJ, Codsi MJ, Bryan J, Iannotti JP. The three-dimensional glenoid vault model can estimate normal glenoid version in osteoarthritis. J Shoulder Elbow Surg. 2008 May-Jun;17(3):487-91. doi: 10.1016/j.jse.2007.09.006. Epub 2008 Feb 20.
PubMed 18282721Scalise JJ, Codsi MJ, Bryan J, Brems JJ, Iannotti JP. The influence of three-dimensional computed tomography images of the shoulder in preoperative planning for total shoulder arthroplasty. J Bone Joint Surg Am. 2008 Nov;90(11):2438-45. doi: 10.2106/JBJS.G.01341.
PubMed 18978413Eisler T, Svensson O, Tengstrom A, Elmstedt E. Patient expectation and satisfaction in revision total hip arthroplasty. J Arthroplasty. 2002 Jun;17(4):457-62. doi: 10.1054/arth.2002.31245.
PubMed 12066276Furnes O, Lie SA, Espehaug B, Vollset SE, Engesaeter LB, Havelin LI. Hip disease and the prognosis of total hip replacements. A review of 53,698 primary total hip replacements reported to the Norwegian Arthroplasty Register 1987-99. J Bone Joint Surg Br. 2001 May;83(4):579-86. doi: 10.1302/0301-620x.83b4.11223.
PubMed 11380136Older J. Charnley low-friction arthroplasty: a worldwide retrospective review at 15 to 20 years. J Arthroplasty. 2002 Sep;17(6):675-80. doi: 10.1054/arth.2002.31973.
PubMed 12216018Phillips CB, Barrett JA, Losina E, Mahomed NN, Lingard EA, Guadagnoli E, Baron JA, Harris WH, Poss R, Katz JN. Incidence rates of dislocation, pulmonary embolism, and deep infection during the first six months after elective total hip replacement. J Bone Joint Surg Am. 2003 Jan;85(1):20-6. doi: 10.2106/00004623-200301000-00004.
PubMed 12533567Parvizi J, Wade FA, Rapuri V, Springer BD, Berry DJ, Hozack WJ. Revision hip arthroplasty for late instability secondary to polyethylene wear. Clin Orthop Relat Res. 2006 Jun;447:66-9. doi: 10.1097/01.blo.0000218751.14989.a6.
PubMed 16672896Alberton GM, High WA, Morrey BF. Dislocation after revision total hip arthroplasty : an analysis of risk factors and treatment options. J Bone Joint Surg Am. 2002 Oct;84(10):1788-92.
PubMed 12377909Dorr LD, Wolf AW, Chandler R, Conaty JP. Classification and treatment of dislocations of total hip arthroplasty. Clin Orthop Relat Res. 1983 Mar;(173):151-8.
PubMed 6825326McCollum DE, Gray WJ. Dislocation after total hip arthroplasty. Causes and prevention. Clin Orthop Relat Res. 1990 Dec;(261):159-70.
PubMed 2245542Robinson RP, Simonian PT, Gradisar IM, Ching RP. Joint motion and surface contact area related to component position in total hip arthroplasty. J Bone Joint Surg Br. 1997 Jan;79(1):140-6. doi: 10.1302/0301-620x.79b1.6842.
PubMed 9020463Mahomed NN, Barrett JA, Katz JN, Phillips CB, Losina E, Lew RA, Guadagnoli E, Harris WH, Poss R, Baron JA. Rates and outcomes of primary and revision total hip replacement in the United States medicare population. J Bone Joint Surg Am. 2003 Jan;85(1):27-32. doi: 10.2106/00004623-200301000-00005.
PubMed 12533568Hafez MA, Chelule KL, Seedhom BB, Sherman KP. Computer-assisted total knee arthroplasty using patient-specific templating. Clin Orthop Relat Res. 2006 Mar;444:184-92. doi: 10.1097/01.blo.0000201148.06454.ef.
PubMed 16446589
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Acetabular Shell Position Using 3D Planning vs. Standard Preoperative Planning: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02204007
- Acronym / sponsor ID
- 14-555
- Conditions
- Arthritis
- Keywords
- Acetabular Shell, Total Hip Arthroplasty, 3D imaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Small number of subjects
- Enrolment
- 36 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Posted 29 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observer-blinded prospective randomized clinical trial to define the efficacy of a new technology developed at the Cleveland Clinic to improve the positioning of the acetabular shell in total hip arthroplasty.The proposed study will enroll patients that have consented to total hip arthroplasty with or without screw fixation for treatment of hip pathology. This treatment is standard of care. Patients will receive standard of care pre- and post-operative care and placement of standard of care implants all of which are commercially available and FDA approved for general use for the clinical indications used in these patients. The only difference in treatment between the groups will be the use of a surrogate bone model to help assist the surgeon visualize the ideal placement of the acetabular component. Diagnostic testing performed specifically related to this study consists of obtaining one pre-operative and one post-operative CT scan. The post-operative scan is to be performed within two weeks of surgery.
The investigators predict that those patients with 3D imaging and bone model will have better acetabular shell placement than those with standard preoperative planning.
Detailed description
The plan is enroll 44 subjects (22 in the standard surgery group and 22 in the experimental surgical group) into this randomized clinical trial. All subjects will have the standard of care indications for THA and will give informed consent for both the surgery and participation in this study. Enrollment will occur as part of the routine office evaluation and will be obtained by the treating surgeon or by the research assistant. Four surgeons (Wael Barsoum, Trevor Murray, Carlos Higuera, and Michael Bloomfield) with surgical experience in total hip arthroplasty will perform the procedures in this study. All subjects within each surgeon's practice who qualify for participation in this study will be approached. Subjects will be enrolled at least 10 days prior to the date of surgery. Ten days is the minimum time necessary to obtain a pre-operative CT scan for surgical planning and to manufacture the surrogate bone model. Patients who are not approached during regular office visits will be contacted by phone and if they are interested, they will be scheduled to arrive to the radiology department to sign the informed consent and receive the preoperative CT scan. Subjects will be randomized into either the experimental or control group at the time of consent by the study coordinator. Subjects in the experimental group will have their pre-operative planning done using the 3D surgical simulator and surrogate bone model will be available for the surgeon during surgery. Subjects in the control group will have their pre-operative planning done using plain film x-ray and two-dimensional (2D) templates.
Eligible subjects for inclusion in the study will be able to receive a pelvic CT scan at the Cleveland Clinic. Additionally, we will obtain standard of care pre- and post-operative x-rays (AP view). For subjects randomized into the experimental group, their CT scan DICOM images will be uploaded into the Cleveland Clinic developed surgical simulator specifically designed for THA at least 10 days prior to surgery. For each experimental subject, the Cleveland Clinic pre-operative planning software will be used to define the optimal size and location of the acetabular components (acetabular shell, and the ultra-high molecular weight polyethylene bearing - UHMWPE). The treating surgeon will virtually place the implant in the simulator software. The specification for shell placement will vary depending on the subject's individual pathology and pelvic morphology, but is expected to fall within the range of 10-35 degrees of anteversion and 30-50 degrees of abduction.
In the control group, each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays. To prepare the acetabulum and place the implants on the day of surgery, surgeons will use standard surgical alignment instruments provided by the manufacturer of the implant. For the experimental group, the surgeon will use CT scan and a 3D preoperative planning software to place the implants virtually. The surgeons are provided with a surrogate bone model with a fabricated acetabular implant placed in the same orientation as was planned in the surgical simulator software, and will use standard surgical instruments provided by the manufacturer of the implant.
The images obtained from the post-operative CT scans will be uploaded into the simulator software for 3D reconstruction. The 3D image of the post-operative pelvis with the implants will be superimposed onto the image of the pre-operative pelvis with the virtually placed implants. Using measurement tools within the software we will compare the position of the actual acetabular component placed in the patient with the desired position specified by the plan. The measurements that will be made are for angular orientations in 3D space (anteversion and inclination). Measurements are accurate to within a fraction of a degree.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D imaging, surrogate bone model | Experimental | Device: 3D imaging & surrogate bone model3D imaging \& surrogate bone model |
| Standard of Care Preoperative Imaging | No intervention | –Patients receiving standard of care preoperative planning prior to total hip arthroplasty. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects to be included in this protocol will be adult males and females of all races and socioeconomic status meeting the following criteria:
- Primary, unilateral Total hip arthroplasty (THA)
- 18 to 85 years old at time of surgery
- Able to get a pre- and post-operative CT scan at the Cleveland Clinic Main Campus at least 10 days prior to surgery
Key exclusion criteria (4 listed)
- Significant metal in the joint that results in metal artifact on the pre--operative CT scan, thereby compromising the ability to visualize the acetabulum on the pre-operative simulator.
- Pregnancy
- Incarceration
- Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.
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 |
|---|---|---|
| 3D imaging & surrogate bone model3D imaging \& surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging | Device | 3D imaging, surrogate bone model |
Primary outcome
Acetabular Shell Version and Inclination
Time frame: within 2 weeks of surgery
A CT scan of all patients will be obtained within 2 weeks of surgery to measure placement (acetabular version \& inclination measured in degrees) of the acetabular shell
1 secondary outcome
Operative Time
Time frame: time of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18328741Codsi MJ, Bennetts C, Gordiev K, Boeck DM, Kwon Y, Brems J, Powell K, Iannotti JP. Normal glenoid vault anatomy and validation of a novel glenoid implant shape. J Shoulder Elbow Surg. 2008 May-Jun;17(3):471-8. doi: 10.1016/j.jse.2007.08.010. Epub 2008 Mar 7.
- Background: PubMed 18218326Scalise JJ, Bryan J, Polster J, Brems JJ, Iannotti JP. Quantitative analysis of glenoid bone loss in osteoarthritis using three-dimensional computed tomography scans. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):328-35. doi: 10.1016/j.jse.2007.07.013. Epub 2008 Jan 22.
- Background: PubMed 18282721Scalise JJ, Codsi MJ, Bryan J, Iannotti JP. The three-dimensional glenoid vault model can estimate normal glenoid version in osteoarthritis. J Shoulder Elbow Surg. 2008 May-Jun;17(3):487-91. doi: 10.1016/j.jse.2007.09.006. Epub 2008 Feb 20.
- Background: PubMed 18978413Scalise JJ, Codsi MJ, Bryan J, Brems JJ, Iannotti JP. The influence of three-dimensional computed tomography images of the shoulder in preoperative planning for total shoulder arthroplasty. J Bone Joint Surg Am. 2008 Nov;90(11):2438-45. doi: 10.2106/JBJS.G.01341.
- Background: PubMed 12066276Eisler T, Svensson O, Tengstrom A, Elmstedt E. Patient expectation and satisfaction in revision total hip arthroplasty. J Arthroplasty. 2002 Jun;17(4):457-62. doi: 10.1054/arth.2002.31245.
- Background: PubMed 11380136Furnes O, Lie SA, Espehaug B, Vollset SE, Engesaeter LB, Havelin LI. Hip disease and the prognosis of total hip replacements. A review of 53,698 primary total hip replacements reported to the Norwegian Arthroplasty Register 1987-99. J Bone Joint Surg Br. 2001 May;83(4):579-86. doi: 10.1302/0301-620x.83b4.11223.
- Background: PubMed 12216018Older J. Charnley low-friction arthroplasty: a worldwide retrospective review at 15 to 20 years. J Arthroplasty. 2002 Sep;17(6):675-80. doi: 10.1054/arth.2002.31973.
- Background: PubMed 12533567Phillips CB, Barrett JA, Losina E, Mahomed NN, Lingard EA, Guadagnoli E, Baron JA, Harris WH, Poss R, Katz JN. Incidence rates of dislocation, pulmonary embolism, and deep infection during the first six months after elective total hip replacement. J Bone Joint Surg Am. 2003 Jan;85(1):20-6. doi: 10.2106/00004623-200301000-00004.
- Background: PubMed 16672896Parvizi J, Wade FA, Rapuri V, Springer BD, Berry DJ, Hozack WJ. Revision hip arthroplasty for late instability secondary to polyethylene wear. Clin Orthop Relat Res. 2006 Jun;447:66-9. doi: 10.1097/01.blo.0000218751.14989.a6.
- Background: PubMed 12377909Alberton GM, High WA, Morrey BF. Dislocation after revision total hip arthroplasty : an analysis of risk factors and treatment options. J Bone Joint Surg Am. 2002 Oct;84(10):1788-92.
- Background: PubMed 6825326Dorr LD, Wolf AW, Chandler R, Conaty JP. Classification and treatment of dislocations of total hip arthroplasty. Clin Orthop Relat Res. 1983 Mar;(173):151-8.
- Background: PubMed 2245542McCollum DE, Gray WJ. Dislocation after total hip arthroplasty. Causes and prevention. Clin Orthop Relat Res. 1990 Dec;(261):159-70.
- 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.
Carlos Higuera, MD principal investigator
The Cleveland Clinic
Alison Klika, MS study director
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D imaging & surrogate bone model in people with Arthritis, run by The Cleveland Clinic 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 29 Mar 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 29 Mar 2017). 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?
Acetabular Shell Version and Inclination (time frame: within 2 weeks of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02204007, which also lists 15 linked publications.
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 29 Mar 2017.