Outcomes of Robotic Total Hip Arthroplasty

Osteoarthritis Clinical Trial

Official title:

Outcomes of Robotic Total Hip Arthroplasty: A Prospective Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01672320
• Other study ID #: 2012P000809
• Status: Withdrawn
• Phase: N/A
• First received: August 10, 2012
• Last updated: November 4, 2013
• Start date: January 2013
• Est. completion date: January 2023

Study information

• Verified date: November 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The objectives of this study are to evaluate the clinical value of robotic-assisted total hip arthroplasty with respect to acetabular cup implantation, and to document the long-term clinical outcome of patients with Total Hip Arthroplasty (THA). IRB approval will be obtained at every study site to evaluate the basic clinical outcomes and post-operative component placement accuracy of each MAKO® THA patient.

The hypothesis is that robotic preparation of the acetabulum will significantly reduce the variability and inaccuracy in the component alignment parameters that lead to post-operative complications, including implant failure.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female

• 20 to 75 years of age

• Subjects requiring primary total hip replacement

• Contralateral hip should be relatively free from arthritis for comparison purposes, specifically with less than a grade of 2 on the Kellgren-Lawrence Scale.

• Subjects diagnosed with osteoarthritis or traumatic arthritis

• Subjects with avascular necrosis

• Subjects who demonstrate the ability to return for follow-up for the next 10 years

Exclusion Criteria:

• Subjects with difficulty understanding protocol for any reason

• Subjects with a limited life span

• Subjects with inflammatory hip disease, previous joint infection, or those requiring hip revision surgery

• Female subjects who are pregnant, or who plan to get pregnant while enrolled in the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	MAKO Surgical Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment/questionaire HOOS	Hip Disability and Osteoarthritis Outcome	Pre-op, 1, 3, 5, 7, 10 years after surgery	No
Other	Assessment/Questionaire UCLA Activty Score	Assesses level of activity	Pre-op, 1, 3, 5, 7, 10 years after surgery	No
Other	Assessment/Questionaire EQ-5D	General health and cost effective analysis	Pre-op, 1, 3, 5, 7, 10 years after surgery	No
Other	Assessment/questionaire	Hip desease specific questionaire	Pre-op, 1, 3, 5, 7, 10 years after surgery	No
Other	Assessment/Questionaire Case Mix Indicator	Identifies comorbidities	Pre-op, 1, 3, 5, 7, 10 years after surgery	No
Primary	Survivorship of Components	Defined as implant remaining in subject.	10 Years	No
Primary	Adverse Events	Protocol deviations, complications, "lost to follow-up"	10 Years	No
Secondary	Retrieval Analysis of implants from revision surgery	When possible, analysis of the THR components that are removed at revision surgery will be anlaysed for signs of component impingment or signs of damage related to component position. These observations will be correlated to the clinical reason for revision.	Up to 10 Years	No