Outcomes of Robotic Total Hip Arthroplasty

NCT01672320 | Withdrawn

• 1 other identifier: 2012P000809
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis

Keywords

Robotic; Arthroplasty; Total Hip Arthroplasty; Cup Positioning; Outcomes

Outcome Measures

Primary Outcomes (2)

• Survivorship of Components

  Defined as implant remaining in subject.

  10 Years

• Adverse Events

  Protocol deviations, complications, "lost to follow-up"

  10 Years

Secondary Outcomes (1)

• Retrieval Analysis of implants from revision surgery

  Up to 10 Years

Other Outcomes (5)

• Assessment/questionaire HOOS

  Pre-op, 1, 3, 5, 7, 10 years after surgery

• Assessment/Questionaire UCLA Activty Score

  Pre-op, 1, 3, 5, 7, 10 years after surgery

• Assessment/Questionaire EQ-5D

  Pre-op, 1, 3, 5, 7, 10 years after surgery

Study Arms (2)

Phase II

An evaluation of long-term outcomes, patient reported outcomes, and radiographic analysis will be conducted prospectively on 500 patients

Phase I

An analysis of post-operative component positioning will be evaluated for 500 patients, retrospectively.

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults requiring a total hip arthroplasty procedure.

You may qualify if:

• Male or female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• MAKO Surgical Corp.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: August 10, 2012
• First Posted: August 24, 2012
• Study Start: January 1, 2013
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: November 5, 2013

Record last verified: 2013-11

Locations

US (1)