Acetabular Shell Positioning Using Patient Specific Instruments

NCT01791738 | Completed Phase 1

• 1 other identifier: CCF 10-1138
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Hip; Rheumatoid Arthritis; Avascular Necrosis

Keywords

Total Hip Arthroplasty (THA); Patient-Specific Instruments; Acetabular Cup Placement; Accuracy

Outcome Measures

Primary Outcomes (1)

• Difference between planned and actual values of Abduction and Version.

  Through 2 weeks after surgery.

Study Arms (2)

Acetabular positioning system

EXPERIMENTAL

Pre-operative planning through 3D software with design and fabrication of patient specific instruments for placement of a guide pin to be used to aid in bone preparation for insertion of an acetabular cup in total hip arthroplasty

Procedure: Acetabular positioning system

Standard total hip arthroplasty

NO INTERVENTION

Each surgeon will use their standard methods of pre-operative planning using pre-operative x-rays, and complete the procedure using standard surgical instruments for total hip arthroplasty.

Interventions

Acetabular positioning system PROCEDURE

Pre-operative planning through 3D software with design and fabrication of patient specific instruments for placement of a guide pin to be used to aid in bone preparation for insertion of an acetabular cup in total hip arthroplasty

Acetabular positioning system

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 direct lateral or posterior THA
• to 85 years old at time of surgery
• Able to get a pre- and post-operative CT scan at the Cleveland Clinic

You may not qualify if:

• The following criteria will exclude subjects from this protocol:
• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Arthritis, Rheumatoid; Osteonecrosis

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wael K Barsoum, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chairman , Orthpaedic Surgery

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 15, 2013
• Study Start: January 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: July 10, 2015

Record last verified: 2015-07

Locations

US (1)