Clinical Trials Logo
  1. Home
  2. Osteoarthritis, Knee
  3. NCT03954912
  4. Details
NCT03954912 Clinical Trial

Comparative Outcomes Between Image-based Versus Imageless Robot-assisted Unicondylar Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

Official title:
Comparative Outcomes Between Image-based (MAKO) Versus Imageless NAVIO Robot-assisted Unicondylar Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03954912
Other study ID # 2/62
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2015
Est. completion date January 1, 2018

Study information
Verified date June 2019
Source Ramathibodi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This prospective cohort study was conducted with the aim of comparing relevant clinical outcomes which included intra (surgical time and blood loss), post-operative outcomes (range of motion, function, complications and revisions) and return to activity between imageless and image-based surgical system in medial unicondylar knee arthroplasty

Description:

this prospective cohort study was conducted between 1st June 2015 and 1st July 2018 at Bhumibol Adulyadej Hospital, Bangkok, Thailand. A total of 33 medial compartment OA knee patients were randomly allocated to MAKO or NAVIO robotic assisted UKA. The outcomes assessed were intra-operative outcomes (operative time, blood loss) and postoperative outcomes (function, complications and revision) at 1 year after surgery.

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date January 1, 2018
Est. primary completion date January 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- patients were those deemed suitable for unicondylar knee arthroplasty surgery

- patients who could give informed consent

- patients who willing to attend the prescribed follow-up.

Exclusion Criteria:

- Patients who have medial osteoarthritis knee with following condition:

1. Ligament insufficiency (anterior cruciate ligament rupture, collateral ligament insufficiency).

2. Inflammatory arthritis

3. A deformity requiring augmentation

4. Neurological movement disorders

5. pathology of the feet, ankles, hips, or opposite knee causing significant pain or gait alterations

- Patients who ultimately required a total knee arthroplasty (valgus greater than 14 degree, multiple compartment osteoarthritis were contraindications to unicondylar knee arthroplasty.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• MAKO assisted unicondylar knee arthroplasty
MAKO assisted
• NAVIO assisted unicondylar knee arthroplasty
NAVIO assisted

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Ramathibodi Hospital Bhumibol Adulyadej Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary operative time operative time in minutes the higher value of blood loss is worse outcome 1 day
Primary calculated total blood loss total blood loss which was calculated using a formula based on patient blood volume and a decrease in hemoglobin 1 day
Secondary post operative complications post operative complications included infection, wound complication, stiffness and revision. the higher number of post operative outcome is the worse outcomes 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT03895489 - Effectiveness of the Journey Total Knee Arthroplasty Versus Two Standard of Care Total Knee Arthroplasty Prostheses N/A
Completed NCT03660943 - A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain Phase 3
Completed NCT04531969 - Comparison of Outpatient and Inpatient Spa Therapy N/A
Completed NCT02848027 - Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment Phase 3
Completed NCT05160246 - The Instant Effect of Kinesiology Taping in Patients With Knee OA N/A
Recruiting NCT06080763 - Biomechanics and Clinical Outcomes in Responders and Non-Responders
Completed NCT03643588 - The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain N/A
Active, not recruiting NCT05100225 - Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis Phase 2
Active, not recruiting NCT04061733 - New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis N/A
Completed NCT04051489 - A Novel Smartphone Application for "Smart" Knee Osteoarthritis Trials
Recruiting NCT05546541 - Epidemiology and Nutrition
Recruiting NCT05447767 - Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg Phase 2
Not yet recruiting NCT04448106 - Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis Phase 2
Not yet recruiting NCT03225911 - Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis N/A
Completed NCT05070871 - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women N/A
Completed NCT05703087 - Positive Cueing in Knee Arthroplasty. N/A
Not yet recruiting NCT06042426 - Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population Phase 4
Completed NCT02944448 - A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee Phase 2
Terminated NCT02615522 - Prospective Post Market Clinical Follow-Up of the Primary Knee Endoprosthesis BPK-S Integration
Completed NCT02905747 - The Effect of Medical Exercise Therapy on Pain, Function and Physical Activity in Patients With Knee Osteoarthritis N/A