Patient Specific Instruments Versus Standard Surgical Instruments

NCT01430468 | Completed Results

• 2 other identifiers: CCF 10-582TECH 09-073
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of Glenoid Component Position Using Patient Specific Instruments Versus Standard Surgical Instruments: A Randomized Prospective Clinical Trial

Conditions

Total Shoulder Arthroplasty

Keywords

Glenoid component position; patient specific instruments

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Intra-operative Photographs

  Intra-operative

Study Arms (2)

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.

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.

Interventions

Glenoid Positioning System PROCEDURE

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

Glenoid Positioning System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (9)

• 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.

  PMID: 18328741 BACKGROUND

• 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.

  PMID: 18381328 BACKGROUND

• 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. doi: 10.1016/j.jse.2006.11.004. Epub 2007 May 16.

  PMID: 17509905 BACKGROUND

• Gutierrez 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.

  PMID: 19047705 BACKGROUND

• 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. doi: 10.1097/01.blo.0000201148.06454.ef.

  PMID: 16446589 BACKGROUND

• 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. doi: 10.1016/j.jse.2004.09.026.

  PMID: 15726070 BACKGROUND

• 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.

  PMID: 18218326 BACKGROUND

• 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.

  PMID: 18978413 BACKGROUND

• 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.

  PMID: 18282721 BACKGROUND

Results Point of Contact

• Title: Joseph P. Iannotti, MD, PhD
• Organization: Cleveland Clinic Foundation

iannotj@ccf.org

216-445-5151

Study Officials

• Joseph P. Iannotti, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Institute Chairman

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: September 8, 2011
• Study Start: September 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 1, 2020
• Results First Posted: March 7, 2017

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)