Performance of MOTO Medial® Unicompartmental Knee Arthroplasty - Full Text View

Purpose

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.

Condition	Intervention
Knee Osteoarthritis Knee Arthritis Knee Pain Chronic	Device: MOTO Medial® UKA


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment
Official Title:	A Prospective, Multi-Center Study To Assess Performance of MOTO Medial® in Unicompartmental Knee Arthroplasty (UKA).

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement

U.S. FDA Resources

Further study details as provided by Medacta USA:

Primary Outcome Measures:

Change from baseline in Knee Society Score Objective [ Time Frame: Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months ]
Assessment of improvement of clinical outcomes following knee replacement surgery using the Knee Society Score Questionnaire
Change from baseline in Knee Osteoarthritis Outcome Score [ Time Frame: Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months ]
Assessment of improvement of activity levels following knee replacement surgery using the Knee Osteoarthritis Score Questionnaire
Change from baseline in Forgotten Joint Score [ Time Frame: post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months ]
Assessment of the improvement of joint specific outcomes following knee replacement surgery using the Forgotten Joint Score Questionnaire.
Knee Society Score [ Time Frame: Baseline ]
Assessment of pre-op expectations questionnaire
Change from baseline in Knee Society Score [ Time Frame: post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months ]
Assessment of the improvement post-op satisfaction following knee replacement surgery using the Knee Society Score questionnaire.
Change from baseline in Veterans Rand 12 Score [ Time Frame: Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months ]
Assessment of the improvement of your health using the Veterans Rand 12 score questionnaire.
Change from baseline in Oxford Knee Score [ Time Frame: Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months ]
Assessment of the improvement of knee function following knee replacement surgery using the Oxford Knee Score questionnaire.
Change from baseline in Medication for Osteoarthritis [ Time Frame: Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months ]
Documentation of osteoarthritis medications
Change from baseline in Knee Wound Assessment [ Time Frame: post-operative 2-6 weeks, 4-8 months ]
Assessment of wound drainage, swelling and infection in surgical knee
Change from baseline in Visual Analog Scale score [ Time Frame: baseline, post-operative 2-6 weeks, 4-8 months ]
Assessment of the improvement of patient knee pain following knee replacement surgery using the VAS score questionnaire.
Severity of osteoarthritis in the knee compartments [ Time Frame: Baseline ]
Determine by radiographic analysis for disease progression
Change from baseline in Knee Alignment [ Time Frame: Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months ]
Determine by radiographic analysis Varus or Valgus
Change from baseline of Implant position fixation [ Time Frame: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months ]
Determine by radiographic analysis by measuring Radio Lucent lines in millimeters.
Change from baseline of implant survivorship [ Time Frame: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months ]
Determine by radiographic analysis of bone fracture, implant fracture, fixation and wear

Secondary Outcome Measures:

Implant survivorship [ Time Frame: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months ]
Reoperations, revisions, removals, and device related adverse events
K & L Grading [ Time Frame: Baseline ]
Assessment of Osteoarthritis Disease Grade of the knee compartment
Demographics [ Time Frame: Baseline ]
Date of birth (age)
Demographics [ Time Frame: Baseline ]
Height in inches, weight in pounds to determine BMI
Demographics [ Time Frame: Baseline ]
Gender of male or female
Prior Knee Treatments [ Time Frame: Baseline ]
Prior treatments of knee such as bracing, medication, injections, arthroscopy, ligament and cartilage procedures
Medical and surgical history [ Time Frame: Baseline ]
Medical and surgical history of patient
Post-operative pain medications [ Time Frame: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months ]
Medications after knee surgery
Return to Work/Activity questionnaire [ Time Frame: post-operative 4-8 months, 9-15 months, 18-30 months ]
Assessment of ability to return to work or other activities following surgery
Implant demographics [ Time Frame: day of surgery ]
Implant femoral and tibial size and poly thickness
Anesthetic [ Time Frame: day of surgery ]
type of anesthesia used during surgery
Estimated blood loss [ Time Frame: day of surgery ]
Volume of blood loss during surgery
Length of surgery [ Time Frame: day of surgery ]
Time in minutes of skin to skin
Length of Stay [ Time Frame: day of surgery ]
Length of stay in hours
Facility type [ Time Frame: day of surgery ]
Facility used for surgery
Tourniquet Time [ Time Frame: day of surgery ]
Tourniquet time in minutes
Complications [ Time Frame: day of surgery, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months ]
Assess adverse events and Serious adverse events


Estimated Enrollment:	269
Anticipated Study Start Date:	August 1, 2017
Estimated Study Completion Date:	December 1, 2025
Estimated Primary Completion Date:	August 1, 2025 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Interventional : MOTO Medial® UKA Interventional : Patients who are planned to undergo a primary medial UKA using the MOTO Medial® will be enrolled.	Device: MOTO Medial® UKA Knee replacement surgery with the MOTO Medial® UKA Other Name: Medial Unicondylar Knee Replacement

Detailed 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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211663

Contacts


Contact: Mukesh Ahuja, MBBS, MS, CPI	312-548-9968	Mahuja@medacta.us.com

Sponsors and Collaborators

Medacta USA

More Information


Responsible Party:	Medacta USA
ClinicalTrials.gov Identifier:	NCT03211663 History of Changes
Other Study ID Numbers:	MUSA-K-MTM-001
Study First Received:	June 28, 2017
Last Updated:	July 5, 2017


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:


Osteoarthritis Osteoarthritis, Knee Arthritis	Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

ClinicalTrials.gov processed this record on July 11, 2017