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Completed Phase 1 Interventional

Acetabular Shell Positioning Using Patient Specific Instruments

ClinicalTrials.gov ID: NCT01791738

Public ClinicalTrials.gov record NCT01791738. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 1:36 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Comparison of Acetabular Shell Position Using Patient Specific Instruments vs. Standard Surgical Instruments: A Randomized Clinical Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The proposed study is a double-blinded randomized controlled trial comparing patient specific instruments with solely standardized instruments and pre-operative planning used for the placement of the acetabular cup prosthesis used in total hip arthroplasty. The investigators will enroll 36 patients who have consented to total hip arthroplasty for treatment of hip pathology. This treatment is a 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. All patients will receive a pre-operative CT scan for surgical planning and comparison with post-operative CT scan. The difference in intervention between the groups will be the creation and use of patient specific instruments from the pre-operative planning session. These instruments will be used for placement of an indexing peripheral guide wire to direct acetabular preparation and placement of the shell assisting standard surgical instruments. Print-offs from the pre-operative plan will also be used in the treatment group. The post-operative scan will be performed within two weeks of the surgery for both the treatment and control groups. The investigators will analyze the difference in acetabular shell placement (acetabular version and abduction angle) from the pre-operatively planned CT scan. These differences will be compared between the control and experimental groups.

Study identification

NCT ID
NCT01791738
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
The Cleveland Clinic
Other
Enrollment
36 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2010
Primary completion
Mar 31, 2012
Completion
Mar 31, 2012
Last update posted
Jul 9, 2015

2011 – 2012

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
The Cleveland Clinic Cleveland Ohio 44195

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01791738, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 9, 2015 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01791738 live on ClinicalTrials.gov.

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