Total Shoulder ArthroplastyTIOSO-GPSNCT01430468
Patient Specific Instruments Versus Standard Surgical Instruments
A study testing Glenoid Positioning System in people with Total Shoulder Arthroplasty, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Comparison of Glenoid Component Position Using Patient Specific Instruments Versus Standard Surgical Instruments: A Randomized Prospective Clinical Trial Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Shoulder Arthroplasty
- What is being tested?
- Glenoid Positioning System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to May 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients otherwise indicated for primary reverse or anatomic total shoulder replacement that are able to get a pre-operative CT scan at the Cleveland Clinic will be considered eligible for enrollment. All patients will be consented in the office as part of the pre-operative consent for surgery and all will need to randomization at the time of surgery
Who cannot join
- Patients will be excluded if they have significant metal in the joint that results in metal artifact on the CT scan, thereby compromising the ability to visualize the glenoid on the pre-operative simulator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Glenoid Component Position Using Patient Specific Instruments Versus Standard Surgical Instruments: A Randomized Prospective Clinical Trial
Comparison of Glenoid Component Position Using Patient Specific Instruments Versus Standard Surgical Instruments: A Randomized Prospective Clinical Trial
Read the detailed description
This is a non blinded prospective randomized clinical trial to define the efficacy of a new technology developed at the Cleveland Clinic to improve the positioning of the glenoid component in total shoulder arthroplasty. The Cleveland Clinic research team has worked on the development and validation of this new technology for the last six years. The investigators have validated the pre-operative planning software and published the results in the peer review literature (1, 7, 8, 9). The investigators have used this software in the planning of total shoulder surgery over the last three years. The investigators have validated the accuracy and reproducibility of the patient-specific instrumentation in both cadaver shoulders and Sawbones models of the shoulder using multiple surgeons. These studies also validated our ability to precisely measure component position using 3D CT scan imaging after placement of the implants in a pre-clinical cadaver study, thereby validating our ability to accurately measure and compare component position between the groups described in this proposed clinical trial. The investigators have also proven the ability of the software and techniques to produce an accurate representation of the glenoid morphology in patients with osteoarthritis or rotator cuff deficient arthritis in 13 patients. This was an IRB approved patient safety study performed at the Cleveland Clinic. The investigators have performed extensive studies of the materials and processes for the fabrication, sterilization and packaging of the patient specific instruments. The investigators have selected materials and processes that have met all of the FDA requirements for use of these materials and processes as clinical devices in vivo. These devices (non implanted instruments) are generally classified by FDA as a Class I device not having significant clinical risk. The investigators have studied the materials and process to produce accurate instruments that meet the clinical specification for fit onto the surrogate glenoid surfaces and maintain this shape and fit after sterilization. These same patient specific instruments have been tested in pre-clinical trials (Sawbones and Cadavers), demonstrating their ability to perform the functions specified with a high level of accuracy and much better than the use of standard generic instruments.
- Conditions
- Total Shoulder Arthroplasty
- Being tested
- Glenoid Positioning System
- Keywords
- Glenoid component position, patient specific instruments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glenoid Positioning SystemProcedure or surgery
Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component
| Study group | Role | What they receive |
|---|---|---|
| Glenoid Positioning System | Experimental | For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments. Receives: Procedure: Glenoid Positioning System |
| Standard Group | No intervention | Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing Glenoid Component Positioning to Pre Operative Planning
Final implant position will be determined by comparing the position of the glenoid component on the post-operative CT scans with the implant position planned pre-operatively on the surgical simulator. These measurements will be in degrees.
Measured: 1 month post op
Secondary outcomes (1)
Intra-operative Photographs
Intra-operative photographs will be used to qualitatively, not quantitatively, to document the surgical steps and may be useful to explain a deviation in the surgery than what would have been expected by the pre-operative simulator. No quantitative data will be collected from the photographs.
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startSep 2010
- Primary completionMay 2011
- Study completionMay 2011
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 (9)Papers the sponsor has linked to this study.
- Other trials for Total Shoulder ArthroplastyStudies 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Iannotti, The Cleveland Clinic
- Investigators
- Joseph P. Iannotti, MD, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430468
- Sponsor's protocol ID
- CCF 10-582
- Other IDs
- TECH 09-073
- Acronym
- TIOSO-GPS
- Status last verified
- Jan 2020
- First submitted
- 1 Sep 2011
- Last updated
- 1 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share IPD with other researchers.
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 18328741Matsen FA 3rd, Clinton J, Lynch J, Bertelsen A, Richardson ML. Glenoid component failure in total shoulder arthroplasty. J Bone Joint Surg Am. 2008 Apr;90(4):885-96. doi: 10.2106/JBJS.G.01263.
PubMed 18381328Franta AK, Lenters TR, Mounce D, Neradilek B, Matsen FA 3rd. The complex characteristics of 282 unsatisfactory shoulder arthroplasties. J Shoulder Elbow Surg. 2007 Sep-Oct;16(5):555-62. doi: 10.1016/j.jse.2006.11.004. Epub 2007 May 16.
PubMed 17509905Gutierrez S, Comiskey CA 4th, Luo ZP, Pupello DR, Frankle MA. Range of impingement-free abduction and adduction deficit after reverse shoulder arthroplasty. Hierarchy of surgical and implant-design-related factors. J Bone Joint Surg Am. 2008 Dec;90(12):2606-15. doi: 10.2106/JBJS.H.00012.
PubMed 19047705Hafez 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 16446589Iannotti JP, Spencer EE, Winter U, Deffenbaugh D, Williams G. Prosthetic positioning in total shoulder arthroplasty. J Shoulder Elbow Surg. 2005 Jan-Feb;14(1 Suppl S):111S-121S. doi: 10.1016/j.jse.2004.09.026.
PubMed 15726070Scalise 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, 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 18978413Scalise 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 18282721
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Glenoid Component Position Using Patient Specific Instruments Versus Standard Surgical Instruments: A Randomized Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT01430468
- Acronym / sponsor ID
- TIOSO-GPS / CCF 10-582
- Conditions
- Total Shoulder Arthroplasty
- Keywords
- Glenoid component position, patient specific instruments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 8 Sep 2011 (estimated)
- Results
- Posted 7 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of Glenoid Component Position Using Patient Specific Instruments Versus Standard Surgical Instruments: A Randomized Prospective Clinical Trial
Detailed description
This is a non blinded prospective randomized clinical trial to define the efficacy of a new technology developed at the Cleveland Clinic to improve the positioning of the glenoid component in total shoulder arthroplasty. The Cleveland Clinic research team has worked on the development and validation of this new technology for the last six years. The investigators have validated the pre-operative planning software and published the results in the peer review literature (1, 7, 8, 9). The investigators have used this software in the planning of total shoulder surgery over the last three years. The investigators have validated the accuracy and reproducibility of the patient-specific instrumentation in both cadaver shoulders and Sawbones models of the shoulder using multiple surgeons. These studies also validated our ability to precisely measure component position using 3D CT scan imaging after placement of the implants in a pre-clinical cadaver study, thereby validating our ability to accurately measure and compare component position between the groups described in this proposed clinical trial. The investigators have also proven the ability of the software and techniques to produce an accurate representation of the glenoid morphology in patients with osteoarthritis or rotator cuff deficient arthritis in 13 patients. This was an IRB approved patient safety study performed at the Cleveland Clinic. The investigators have performed extensive studies of the materials and processes for the fabrication, sterilization and packaging of the patient specific instruments. The investigators have selected materials and processes that have met all of the FDA requirements for use of these materials and processes as clinical devices in vivo. These devices (non implanted instruments) are generally classified by FDA as a Class I device not having significant clinical risk. The investigators have studied the materials and process to produce accurate instruments that meet the clinical specification for fit onto the surrogate glenoid surfaces and maintain this shape and fit after sterilization. These same patient specific instruments have been tested in pre-clinical trials (Sawbones and Cadavers), demonstrating their ability to perform the functions specified with a high level of accuracy and much better than the use of standard generic instruments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glenoid Positioning System | Experimental | Procedure: Glenoid Positioning SystemFor the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments. |
| Standard Group | No intervention | –Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients otherwise indicated for primary reverse or anatomic total shoulder replacement that are able to get a pre-operative CT scan at the Cleveland Clinic will be considered eligible for enrollment. All patients will be consented in the office as part of the pre-operative consent for surgery and all will need to randomization at the time of surgery
Key exclusion criteria (1 listed)
- Patients will be excluded if they have significant metal in the joint that results in metal artifact on the CT scan, thereby compromising the ability to visualize the glenoid on the pre-operative simulator.
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 |
|---|---|---|
| Glenoid Positioning SystemDesign and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component | Procedure or surgery | Glenoid Positioning System |
Primary outcome
Comparing Glenoid Component Positioning to Pre Operative Planning
Time frame: 1 month post op
Final implant position will be determined by comparing the position of the glenoid component on the post-operative CT scans with the implant position planned pre-operatively on the surgical simulator. These measurements will be in degrees.
1 secondary outcome
Intra-operative Photographs
Time frame: Intra-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- 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 18381328Matsen FA 3rd, Clinton J, Lynch J, Bertelsen A, Richardson ML. Glenoid component failure in total shoulder arthroplasty. J Bone Joint Surg Am. 2008 Apr;90(4):885-96. doi: 10.2106/JBJS.G.01263.
- Background: PubMed 17509905Franta AK, Lenters TR, Mounce D, Neradilek B, Matsen FA 3rd. The complex characteristics of 282 unsatisfactory shoulder arthroplasties. J Shoulder Elbow Surg. 2007 Sep-Oct;16(5):555-62. doi: 10.1016/j.jse.2006.11.004. Epub 2007 May 16.
- Background: PubMed 19047705Gutierrez S, Comiskey CA 4th, Luo ZP, Pupello DR, Frankle MA. Range of impingement-free abduction and adduction deficit after reverse shoulder arthroplasty. Hierarchy of surgical and implant-design-related factors. J Bone Joint Surg Am. 2008 Dec;90(12):2606-15. doi: 10.2106/JBJS.H.00012.
- Background: PubMed 16446589Hafez 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.
- Background: PubMed 15726070Iannotti JP, Spencer EE, Winter U, Deffenbaugh D, Williams G. Prosthetic positioning in total shoulder arthroplasty. J Shoulder Elbow Surg. 2005 Jan-Feb;14(1 Suppl S):111S-121S. doi: 10.1016/j.jse.2004.09.026.
- 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 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 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.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers.
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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.
Joseph P. Iannotti, MD, PhD principal investigator
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 Glenoid Positioning System in people with Total Shoulder Arthroplasty, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Jun 2020. 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 7 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?
Comparing Glenoid Component Positioning to Pre Operative Planning (time frame: 1 month post op). 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 NCT01430468, which also lists 9 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 1 Jun 2020.