Clinical trial NCT05037734: A Randomized Controlled Trial for Partial Knee Arthroplasty
Official title: A Post-Market, Multicenter, Randomized Controlled Trial of the ROSA® Partial Knee System for Unicompartmental Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Degenerative Joint Disease of Knee
Osteoarthritis
Traumatic Arthritis
Varus Deformity
Knee Pain Chronic
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2021-09-08
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, multi-center, two-arm, randomized, controlled post-market study to evaluate and compare the clinical accuracy of component placement in robotic-assisted UKA and that of traditional methods.

Detailed description: Sites will enroll participants into two separate arms for this study (rUKA and Conventional Instrumentation), following the assigned randomization. Consecutive patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for participation in the study and will be pre-screened for participation in the informed consent process.

The primary objective of this study is to evaluate and compare the accuracy of the ROSA® Partial Knee System in regards to implant placement with that of traditional instrumentation. This will include the assessment of the planned vs. actual component positioning.

Secondary Objectives include the evaluation of safety and efficacy of this system and will include the assessment of common adverse events, physical exam findings, radiologic results and patient reported outcome measures.

Data collection will occur at the following intervals: Pre-operative, Operative, 6-weeks, 3-months, 1-year, and 2-years. Enrollment for the study is anticipated to last approximately 12-18 months. Allowing for 24 months of follow-up, the total estimated study time to final-patient final-visit will be approximately 42 months.

Eligibility criteria: Inclusion Criteria:

1. Patient meets the approved indications for use in accordance with product labeling for both the Persona Partial Knee System and the ROSA® Partial Knee System.
2. Body mass index ≤40 kg/m2
3. Patient is of legal age and skeletally mature
4. Patient is willing and able to provide informed consent.
5. Patient is willing to be randomized into one of two study groups of UKA performed using ROSA® and UKA using Conventional Instrumentation
6. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol.
7. Patient qualifies for primary UKA based on investigator's clinical judgement and has an intact anterior cruciate ligament.
8. Independent of study participation, patient is a candidate for the commercially available Persona Partial Knee System.

Exclusion Criteria:

1. Independent of study participation, patient meets any of the contraindications for use in accordance with product labeling of the Persona Partial Knee System and/or the ROSA® Partial Knee System.
2. Orthopaedic procedure or pain management study of any joint within the last or next 6 months; furthermore, bilateral enrollment is excluded in this study.
3. Prior ACL Repair
4. Moderate to severe patello-femoral arthritis, that in the opinion of the investigator, would require patella-femoral arthroplasty.
5. Patient is unwilling to sign the Informed Consent.
6. Would, in the investigator's opinion, be unwilling or unable to comply with the postoperative care instructions or study follow-up schedule.
7. Patient is considered a member of a protected/vulnerable population (Pregnant, prisoner, mentally incompetent, etc.).
8. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation.
9. Patient has a condition which would, in the judgement of the investigator, place the patient at undue risk or interfere with the conduct of the study.

Primary outcomes:
measure: Accuracy of implant position
timeFrame: 6 Weeks
Secondary outcomes:
measure: Evaluation of Patient safety
timeFrame: 24 months
measure: Evaluation of range of motion
timeFrame: 24 months
measure: Evaluation of Instability
timeFrame: 24 months
measure: Patient Reported Outcome Measure (Oxford Knee Score)
timeFrame: 24 months
measure: Patient Reported Outcome Measure (KOOS-12)
timeFrame: 24 months
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 24 Months
measure: Subject Satisfaction
timeFrame: 24 Months
Other outcomes:
Locations:
city: Jackson
country: United States
facility: Mississippi Sports Medicine and Orthopaedic Center
state: Mississippi
Study officials:
affiliation: Zimmer Biomet
name: Hillary Overholser
role: STUDY_DIRECTOR
References: