Osteoarthritis Clinical Trial
Official title:
Outcomes of Robotic Total Hip Arthroplasty: A Prospective Study
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.
Status | Withdrawn |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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | MAKO Surgical Corp. |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04657926 -
A Trial of APPA in the Treatment of Knee Osteoarthritis
|
Phase 2 | |
Completed |
NCT02536833 -
A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
|
Phase 2 | |
Completed |
NCT03014037 -
Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration
|
N/A | |
Recruiting |
NCT05937542 -
A Qualitative Investigation of CLEAT Participants
|
||
Completed |
NCT03644615 -
A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT06061367 -
Muscles Strength and Gait Parameteres After TKA
|
||
Withdrawn |
NCT04976972 -
A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation
|
N/A | |
Completed |
NCT05496205 -
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT03850665 -
Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach
|
N/A | |
Completed |
NCT02826902 -
Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial
|
N/A | |
Completed |
NCT04402502 -
Dynamic 4DCT to Examine Wrist Carpal Mechanics
|
N/A | |
Completed |
NCT02923700 -
Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial
|
Phase 4 | |
Completed |
NCT04564053 -
Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants
|
Phase 1 | |
Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
Not yet recruiting |
NCT05036174 -
Diphenhydramine Ointment for Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT02912429 -
Onlay vs. Inlay Patellofemoral Arthroplasty
|
N/A | |
Recruiting |
NCT02666443 -
Low Dose Dexamethasone in Supraclavicular Blocks
|
N/A | |
Active, not recruiting |
NCT02723929 -
Effects of tDCS and tUS on Pain Perception in OA of the Knee
|
||
Terminated |
NCT02820766 -
Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting
|
N/A | |
Withdrawn |
NCT02921594 -
Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties
|
N/A |