Results Between Robotic-Assisted and Manual Total Knee Arthroplasty With Kinematic Alignment
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Jakub Błaszczyk
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- HKA angle
Overview
Brief Summary
This randomised controlled trial will include patients with end-stage osteoarthritis of the knee undergoing primary TKR. Patients meeting the criteria that consent to be in the study will be randomised at a ratio of 1:1 to either manual TKR or robotic-assisted TKR. The primary objective will assess pre- and postoperative HKA angle, CPAK and range of motion using goniometer to compare two groups.The secondary objectives are to compare patient expectation, functional ability, quality of life using functional 48-point Oxford Knee Score and Forgotten joint score.
Detailed Description
This randomised controlled trial will include patients with end-stage osteoarthritis of the knee undergoing primary TKR. Patients meeting the criteria that consent to be in the study will be randomised at a ratio of 1:1 to either manual TKR or robotic-assisted TKR. The primary objective will assess pre- and postoperative HKA angle, CPAK and range of motion using goniometer to compare two groups.The secondary objectives are to compare patient expectation, functional ability, quality of life using functional 48-point Oxford Knee Score and Forgotten joint score.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •gonarthrosis
Exclusion Criteria
- •heavy systemic diseases
Arms & Interventions
manual TKA
We prepare TKA using manual intrumentation
Intervention: postoperative Oxford Knee Score (Other)
manual TKA
We prepare TKA using manual intrumentation
Intervention: postoperative CPAK (Other)
manual TKA
We prepare TKA using manual intrumentation
Intervention: preoperative Oxford Knee Score (Other)
manual TKA
We prepare TKA using manual intrumentation
Intervention: postoperative range-of-motion (Other)
manual TKA
We prepare TKA using manual intrumentation
Intervention: preoperative Forgotten Joint Score (Other)
manual TKA
We prepare TKA using manual intrumentation
Intervention: preoperative range-of-motion (Other)
manual TKA
We prepare TKA using manual intrumentation
Intervention: postoperative HKA (Other)
manual TKA
We prepare TKA using manual intrumentation
Intervention: preoperative HKA (Other)
manual TKA
We prepare TKA using manual intrumentation
Intervention: preoperative CPAK (Other)
manual TKA
We prepare TKA using manual intrumentation
Intervention: postoperative Forgotten Joint Score (Other)
robotic assisted TKA
We prepare TKA using robotic arm
Intervention: preoperative HKA (Other)
robotic assisted TKA
We prepare TKA using robotic arm
Intervention: preoperative CPAK (Other)
robotic assisted TKA
We prepare TKA using robotic arm
Intervention: preoperative Oxford Knee Score (Other)
robotic assisted TKA
We prepare TKA using robotic arm
Intervention: preoperative Forgotten Joint Score (Other)
robotic assisted TKA
We prepare TKA using robotic arm
Intervention: preoperative range-of-motion (Other)
robotic assisted TKA
We prepare TKA using robotic arm
Intervention: postoperative HKA (Other)
robotic assisted TKA
We prepare TKA using robotic arm
Intervention: postoperative CPAK (Other)
robotic assisted TKA
We prepare TKA using robotic arm
Intervention: postoperative range-of-motion (Other)
robotic assisted TKA
We prepare TKA using robotic arm
Intervention: postoperative Oxford Knee Score (Other)
robotic assisted TKA
We prepare TKA using robotic arm
Intervention: postoperative Forgotten Joint Score (Other)
Outcomes
Primary Outcomes
HKA angle
Time Frame: 3,6, 12 moths after surgery
HKA angle
Time Frame: 3,6,12 months after surgery
measure pre and postoperative HKA angle
Secondary Outcomes
No secondary outcomes reported
Investigators
Jakub Błaszczyk
doctor
Jan Biziel University Hospital No 2 in Bydgoszcz