Clinical trial NCT06627699: Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® System
Official title: Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® System
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Knee Osteoarthristis
Total Knee Anthroplasty
Keywords: Registry
Primary TKA
Total Knee Arthroplasty
Total Knee Replacement
Lead sponsor: Maxx Orthopedics Inc
Sponsor class: INDUSTRY
First posted: 2024-10-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The registry population will consist of adult male and female subjects who are suffering from moderate to severe symptoms of the following diagnoses: painful degenerative knee disease.

Brief summary: In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring.

Detailed description: In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring.

To maintain equal site distribution per device, patient recruitment will include up to a total of twenty (20) registry sites and thirty (30) primary TKA candidates per site / surgeon for a total of 600 registry patients. A total of no more than 200 patients across all sites will be recruited per level of constraint (e.g.: 200 CR, 200:PS, 200:UC) for this registry with a 10-month accrual target from study initiation per site (\~3 patients consented / month).

Eligibility criteria: INCLUSION CRITERIA:

Candidates for this registry must meet ALL of the following criteria:

* Patient is \> 18 years of age
* Patient has failed attempts at non-operative conservative therapy
* Patient has participated in the informed consent process and signed an IRB approved informed consent
* Patient is scheduled to undergo unilateral or bilateral primary TKA of the knee

EXCLUSION CRITERIA:

Candidates will be excluded from the evaluation if ANY of the following apply:

* Patients with previous TKA, UKA, HTO or knee fusion of the indicated knee
* Patients that have undergone previous surgery of indicated knee for tumor, trauma or fracture
* Evidence of active or suspected (systemic or local) infection at time of surgery
* Other significant disabling problems from the musculoskeletal system than in the knee (i.e.: muscular dystrophy, polio, neuropathic joints)
* Patients with or having; malignancy - active malignancy, Paget's disease, renal osteodystrophy, immunologically suppressed, sickle cell anemia and systemic lupus erythematosus
* Patients with neuromuscular or neurosensory deficit
* Women who are pregnant
* Prisoner or transient
* Recent history of known narcotic abuse
* Any significant psychological disturbance past or present, that could impair the consent process or ability to complete subject self-report questionnaires

Primary outcomes:
measure: Device Survivorship
timeFrame: 2 years
Secondary outcomes:
measure: Original Knee Society Scale (KSS)
timeFrame: 3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months
measure: Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR)
timeFrame: 3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months
measure: Patient Reported Outcomes Measurement Information System (PROMIS Global-10)
timeFrame: 3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months
measure: Visual Analog Scale (VAS)
timeFrame: 3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months
measure: Forgotten Joint Score (FJS-12)
timeFrame: 3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months
Other outcomes:
measure: Radiography (plain-film radiography as per standard of care - independent collective site assessment)
timeFrame: 3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months
measure: Adverse Events
timeFrame: 3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months
Locations:
city: Leawood
country: United States
facility: Ascentist Healthcare
state: Kansas
city: San Antonio
country: United States
facility: South Texas Bone & Joint Institute
state: Texas
Study officials:
affiliation: Chief of Orthopedics, Englewood Hospital
name: Asit Shah, MD, PhD
role: STUDY_CHAIR
References:
citation: Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93.
citation: Thomsen MG, Latifi R, Kallemose T, Barfod KW, Husted H, Troelsen A. Good validity and reliability of the forgotten joint score in evaluating the outcome of total knee arthroplasty. Acta Orthop. 2016 Jun;87(3):280-5. doi: 10.3109/17453674.2016.1156934. Epub 2016 Mar 3.
citation: Shim J, Hamilton DF. Comparative responsiveness of the PROMIS-10 Global Health and EQ-5D questionnaires in patients undergoing total knee arthroplasty. Bone Joint J. 2019 Jul;101-B(7):832-837. doi: 10.1302/0301-620X.101B7.BJJ-2018-1543.R1.
citation: Lyman S, Lee YY, Franklin PD, Li W, Cross MB, Padgett DE. Validation of the KOOS, JR: A Short-form Knee Arthroplasty Outcomes Survey. Clin Orthop Relat Res. 2016 Jun;474(6):1461-71. doi: 10.1007/s11999-016-4719-1. Epub 2016 Feb 29.
citation: Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4.