Real Time 3D Imaging and Surrogate Bone Model

Arthritis Clinical Trial

Official title:

Comparison of Acetabular Shell Position Using 3D Planning vs. Standard Preoperative Planning: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02204007
• Other study ID #: 14-555
• Status: Recruiting
• Phase: N/A
• First received: July 28, 2014
• Last updated: July 29, 2014
• Start date: June 2014
• Est. completion date: April 2015

Study information

• Verified date: July 2014
• Source: The Cleveland Clinic
• Contact: Alison Klika, MS
• Phone: (216) 444-4954
• Email: klikaa[@]ccf.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: April 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis

Intervention

Device:
• 3D imaging & surrogate bone model
3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (15)

Alberton 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-A(10):1788-92. — View Citation

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

Dorr 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. — View Citation

Eisler T, Svensson O, Tengström A, Elmstedt E. Patient expectation and satisfaction in revision total hip arthroplasty. J Arthroplasty. 2002 Jun;17(4):457-62. — View Citation

Furnes 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. — 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

Mahomed 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-A(1):27-32. — View Citation

McCollum DE, Gray WJ. Dislocation after total hip arthroplasty. Causes and prevention. Clin Orthop Relat Res. 1990 Dec;(261):159-70. — View Citation

Older J. Charnley low-friction arthroplasty: a worldwide retrospective review at 15 to 20 years. J Arthroplasty. 2002 Sep;17(6):675-80. — View Citation

Parvizi 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. — View Citation

Phillips 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-A(1):20-6. — View Citation

Robinson 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. — 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

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acetabular Shell Version and Inclination	A CT scan of all patients will be obtained within 2 weeks of surgery to measure placement (Version & Inclination) of the acetabular shell	within 2 weeks of surgery	No
Secondary	Operative Time	Duration of the surgical case	time of surgery	No

External Links

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