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

NCT06627699 | Not Yet Recruiting DMC

• 1 other identifier: PK-00002
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Osteoarthristis; Total Knee Anthroplasty

Keywords

Registry; Primary TKA; Total Knee Arthroplasty; Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• Device Survivorship

  Revision / re-operation post-operatively due to device / device composite failure. An anticipated benefit of the device is that it is more conforming at higher degrees of flexion, which could potentially result in reduced polyethylene wear and improved survivorship over the longer-term. To assess this aspect of the device in addition to safety over the short-, intermediate- and long-term, survivorship analyses will be conducted at the targeted follow-up landmark timepoints. There will be 3 survivorship endpoints: * Revision of any component (including insert) for any reason * Revision of any component (including insert) for any reason except infection

  2 years

Secondary Outcomes (5)

• Original Knee Society Scale (KSS)

  3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months

• Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR)

  3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months

• Patient Reported Outcomes Measurement Information System (PROMIS Global-10)

  3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months

• Visual Analog Scale (VAS)

  3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months

• Forgotten Joint Score (FJS-12)

  3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months

Other Outcomes (2)

• Radiography (plain-film radiography as per standard of care - independent collective site assessment)

  3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months

• Adverse Events

  3-6 Weeks, 3 Months, 6 Months, 12 Months, 24 Months

Study Arms (1)

Patients receiving the Maxx Freedom Total Knee System for primary TKA

TARGETED PATIENTS Adult male and female patients greater than 18 years of age Candidate for primary TKA GENERAL EXCLUSIONS Active infection Revision / conversion TKA (Prior UKA or HTO)

Device: Total Knee Arthroplasty

Interventions

Total Knee Arthroplasty DEVICE

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

Patients receiving the Maxx Freedom Total Knee System for primary TKA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maxx Orthopedics Inc: lead

Study Sites (2)

Ascentist Healthcare

Leawood, Kansas, 66211, United States

Location

South Texas Bone & Joint Institute

San Antonio, Texas, 78249, United States

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• Registry sponsor home page

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Asit Shah, MD, PhD

  Chief of Orthopedics, Englewood Hospital

  STUDY CHAIR

Central Study Contacts

Nach Dave, MS, RPh

CONTACT

732-718-1385; nach.dave@maxxortho.com

Corey Perine, BS, MBA

CONTACT

215-432-4323; corey.perine@maxxortho.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 4, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

US (2)