Total Shoulder Arthroplasty Clinical Trial
— TIOSO-GPSOfficial title:
Comparison of Glenoid Component Position Using Patient Specific Instruments Versus Standard Surgical Instruments: A Randomized Prospective Clinical Trial
Verified date | January 2020 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Comparison of Glenoid Component Position Using Patient Specific Instruments Versus Standard Surgical Instruments: A Randomized Prospective Clinical Trial
Status | Completed |
Enrollment | 44 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
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. — View Citation
Franta 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. Epub 2007 May 16. — View Citation
Gutiérrez 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. — View Citation
Hafez 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. — View Citation
Iannotti 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. — View Citation
Matsen 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. — View Citation
Scalise 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. — View Citation
Scalise 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. — View Citation
Scalise 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 month post op | |
Secondary | 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. | Intra-operative |
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