NCT02204007

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

March 29, 2017

Completed
Last Updated

March 29, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

July 28, 2014

Results QC Date

December 20, 2016

Last Update Submit

February 15, 2017

Conditions

Arthritis

Keywords

Acetabular ShellTotal Hip Arthroplasty3D imaging

Outcome Measures

Primary Outcomes (1)

  • 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

    within 2 weeks of surgery

Secondary Outcomes (1)

  • Operative Time

    time of surgery

Study Arms (2)

3D imaging, surrogate bone model

EXPERIMENTAL

3D imaging \& surrogate bone model

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.

Interventions

3D imaging & surrogate bone modelDEVICE

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

3D imaging, surrogate bone model

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (15)

  • 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: 18328741BACKGROUND

  • 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: 18218326BACKGROUND

  • 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: 18282721BACKGROUND

  • 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: 18978413BACKGROUND

  • Eisler 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.

    PMID: 12066276BACKGROUND

  • 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. doi: 10.1302/0301-620x.83b4.11223.

    PMID: 11380136BACKGROUND

  • Older 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.

    PMID: 12216018BACKGROUND

  • 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(1):20-6. doi: 10.2106/00004623-200301000-00004.

    PMID: 12533567BACKGROUND

  • 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. doi: 10.1097/01.blo.0000218751.14989.a6.

    PMID: 16672896BACKGROUND

  • 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(10):1788-92.

    PMID: 12377909BACKGROUND

  • 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.

    PMID: 6825326BACKGROUND

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

    PMID: 2245542BACKGROUND

  • 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. doi: 10.1302/0301-620x.79b1.6842.

    PMID: 9020463BACKGROUND

  • 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(1):27-32. doi: 10.2106/00004623-200301000-00005.

    PMID: 12533568BACKGROUND

  • 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: 16446589BACKGROUND

Related Links

MeSH Terms

Conditions

Arthritis

Interventions

Imaging, Three-Dimensional

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

Title
Dr. Carlos A Higuera, MD
Organization
Cleveland Clinic Foundation
higuerc@ccf.org
2166361136

Study Officials

  • Carlos Higuera, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • Alison Klika, MS

    The Cleveland Clinic

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
SPONSOR

Study Record Dates

First Submitted

July 28, 2014

First Posted

July 30, 2014

Study Start

June 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 29, 2017

Results First Posted

March 29, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)