Acetabular Shell Positioning Using Patient Specific Instruments

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Wael Barsoum, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01791738
First received: February 7, 2013
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Hip
Rheumatoid Arthritis
Avascular Necrosis
Procedure: Acetabular positioning system
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Acetabular Shell Position Using Patient Specific Instruments vs. Standard Surgical Instruments: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Difference between planned and actual values of Abduction and Version. [ Time Frame: Through 2 weeks after surgery. ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acetabular positioning system
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
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
No Intervention: Standard total hip arthroplasty
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.

Detailed Description:

No further details to report.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 direct lateral or posterior THA
  • 18 to 85 years old at time of surgery
  • Able to get a pre- and post-operative CT scan at the Cleveland Clinic

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01791738

Locations
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Wael K Barsoum, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Wael Barsoum, Vice Chairman , Orthpaedic Surgery, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01791738     History of Changes
Other Study ID Numbers: CCF 10-1138
Study First Received: February 7, 2013
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Total Hip Arthroplasty (THA)
Patient-Specific Instruments
Acetabular Cup Placement
Accuracy

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Necrosis
Osteonecrosis
Osteoarthritis
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Bone Diseases

ClinicalTrials.gov processed this record on July 29, 2014