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Recruiting NCT06627699

Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® System

— Observational Knee Osteoarthristis Total Knee Anthroplasty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Total Knee Arthroplasty.
Who it may be relevant to
Registry conditions: Knee Osteoarthristis, Total Knee Anthroplasty. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Device Total Knee Arthroplasty
    Post-Market Surveillance of the Freedom Total Knee System for Primary TKA

Primary outcome measures

  • Device Survivorship [Time frame: 2 years]
Secondary outcome measures (5)
  • Original Knee Society Scale (KSS) [Time frame: 3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months]
  • Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR) [Time frame: 3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months]
  • Patient Reported Outcomes Measurement Information System (PROMIS Global-10) [Time frame: 3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months]
  • Visual Analog Scale (VAS) [Time frame: 3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months]
  • Forgotten Joint Score (FJS-12) [Time frame: 3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • Ascentist Healthcare — Leawood
  • South Texas Bone & Joint Institute — San Antonio

Publications

  • 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. PMID 18467932
  • 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. PMID 26937689
  • 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. PMID 31256677
  • 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. PMID 26926773
  • 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. PMID 2805470

Identifiers

NCT: NCT06627699 · PK-00002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗