Performance of MOTO Medial® Unicompartmental Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

A Prospective, Multi-Center Study To Assess Performance of MOTO Medial® in Unicompartmental Knee Arthroplasty (UKA).

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03211663
• Other study ID #: MUSA-K-MTM-001
• Status: Active, not recruiting
• Start date: October 9, 2017
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: Medacta USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, multi-center study, designed to assess mid-term performance of the MOTO Medial® Unicompartmental Knee Arthroplasty (UKA), with patient report outcomes, clinical findings and radiographic analysis.

Description:

This is a prospective, multi-center study, designed to assess mid-term performance of the MOTO Medial® UKA, with patient report outcomes, clinical findings and radiographic analysis. Additionally, several perioperative factors, medical and surgical history will be evaluated. Implant survival and complications will be detailed throughout the study. Data from pre-operative evaluation, day of surgery, and post-operatively at 4 weeks, 6 months, and years 1, 2 & 5, will be collected.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 269
• Est. completion date: December 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF).

• Ability to understand and provide written authorization for use and disclosure of personal health information.

• Subject who are able and willing to comply with the study protocol and follow-up visits.

• Must be 18 years or older to participate.

• Subjects must have medial knee disease in the affected knee compliant with the FDA-approved indications for use of MOTO Medial® UKA.

• Must have had no prior arthroplasty to the medial compartment of the study knee.

• Subjects must be able to return for the follow-up appointments, and have the mental capacity to cooperate and complete Patient Reported Outcome questionnaires, physical exam and radiographs.

Exclusion Criteria:

• Knee ligament instability (deficiency of cruciate or collateral ligaments)

• Inflammatory Arthritis

• History of prior knee infection

• History of Alcoholism or Drug Abuse

• Currently on chemotherapy or radiation therapy for neoplastic disease. Medacta MOTO Medial® Version 1 Confidential Page 9 of 36 June 5, 2017

• Currently on immunosuppressive medications including steroids

• History of known sensitivity or allergy to materials used in orthopedic implants, specifically Titanium and Cobalt-Chrome alloys

• Habitual use of narcotic pain medications prior to surgery (more than 3 doses or pills per week)

• History of metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis (e.g., Osteomalacia, Ricketts)

• History of chronic pain issues for reasons other than knee pain.

• Women who are pregnant.

• Psychiatric illness

• Any patient, in the opinion of the investigator, is unable to fully comply with the surgical, rehabilitation, or follow-up aspects of this procedure.

• Prior joint arthroplasty on the target knee, including prior medial UKA (revision), lateral UKA, or Patellofemoral Joint

• Prior high tibial osteotomy (HTO).

Related Conditions & MeSH terms

• Knee Arthritis
• Knee Osteoarthritis
• Knee Pain Chronic
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• MOTO Medial® UKA
Knee replacement surgery with the MOTO Medial® UKA

Locations

Country	Name	City	State
United States	Ortho Montana	Billings	Montana
United States	Duke University	Durham	North Carolina
United States	Unova Health Clinic	Lady Lake	Florida
United States	Ellis & Badenhausen Orthopaedics PSC	Louisville	Kentucky
United States	Whole Health Joint Replacement	Meadville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medacta USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Knee Society Score Objective	Assessment of improvement of clinical outcomes following knee replacement surgery using the Knee Society Score Questionnaire	Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Primary	Change from baseline in Knee Osteoarthritis Outcome Score	Assessment of improvement of activity levels following knee replacement surgery using the Knee Osteoarthritis Score Questionnaire	Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Primary	Change from baseline in Forgotten Joint Score	Assessment of the improvement of joint specific outcomes following knee replacement surgery using the Forgotten Joint Score Questionnaire.	post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Primary	Knee Society Score	Assessment of pre-op expectations questionnaire	Baseline
Primary	Change from baseline in Knee Society Score	Assessment of the improvement post-op satisfaction following knee replacement surgery using the Knee Society Score questionnaire.	post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Primary	Change from baseline in Veterans Rand 12 Score	Assessment of the improvement of your health using the Veterans Rand 12 score questionnaire.	Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Primary	Change from baseline in Oxford Knee Score	Assessment of the improvement of knee function following knee replacement surgery using the Oxford Knee Score questionnaire.	Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Primary	Change from baseline in Medication for Osteoarthritis	Documentation of osteoarthritis medications	Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Primary	Change from baseline in Knee Wound Assessment	Assessment of wound drainage, swelling and infection in surgical knee	post-operative 2-6 weeks, 4-8 months
Primary	Change from baseline in Visual Analog Scale score	Assessment of the improvement of patient knee pain following knee replacement surgery using the VAS score questionnaire.	baseline, post-operative 2-6 weeks, 4-8 months
Primary	Severity of osteoarthritis in the knee compartments	Determine by radiographic analysis for disease progression	Baseline
Primary	Change from baseline in Knee Alignment	Determine by radiographic analysis Varus or Valgus	Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Primary	Change from baseline of Implant position fixation	Determine by radiographic analysis by measuring Radio Lucent lines in millimeters.	post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Primary	Change from baseline of implant survivorship	Determine by radiographic analysis of bone fracture, implant fracture, fixation and wear	post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Secondary	Number of knee Implant faliures	Reoperations, revisions, removals, and device related adverse events	post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Secondary	K & L Grading	Assessment of Osteoarthritis Disease Grade of the knee compartment	Baseline
Secondary	Age of patient	Date of birth (age)	Baseline
Secondary	Demographics	Height in inches, weight in pounds to determine BMI	Baseline
Secondary	Number of male or female patients	Gender description male or female	Baseline
Secondary	Occurrence of Knee Treatments prior to surgery	Prior treatments of knee such as bracing, medication, injections, arthroscopy, ligament and cartilage procedures	Baseline
Secondary	Occurrence of prior medical and surgical history	Medical and surgical history of patient prior to knee surgery	Baseline
Secondary	Post-operative pain medications	Medications after knee surgery	post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Secondary	Return to Work/Activity questionnaire	Assessment of ability to return to work or other activities following surgery	post-operative 4-8 months, 9-15 months, 18-30 months
Secondary	Implant demographics	Implant femoral and tibial size and poly thickness	day of surgery
Secondary	Anesthetic	type of anesthesia used during surgery	day of surgery
Secondary	Estimated blood loss	Volume of blood loss during surgery	day of surgery
Secondary	Length of surgery	Time in minutes of skin to skin	day of surgery
Secondary	Length of Hospital Stay	Length of stay in hours	day of surgery
Secondary	Frequency of Facility type used for knee surgery	Type of facility used for knee surgery	day of surgery
Secondary	Tourniquet Time	Tourniquet time in minutes	day of surgery
Secondary	Complications	Assess adverse events and Serious adverse events	day of surgery, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months