Recruiting

Freedom Total Knee

Sponsor:

Maxx Orthopedics Inc

Code:

NCT06627673

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Total Knee Arthroplasty

Study Details

Brief summary:

The purpose of this investigational device exemption (IDE) study is to monitor the performance (safety and efficacy) of the Maxx Orthopedics, Freedom Total Knee® System, with a femoral component of similar design, manufactured from polyether-ether-ketone (PEEK).

Conditions

Knee Osteoarthritis

Study ID

NCT06627673

Start date

Jan 1, 2026

Status verified date

Jun, 2026

Completion date

Mar 1, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male and female subjects 18 years of age or older.
  • Subjects with a primary diagnosis of end-stage symptomatic unilateral primary knee osteoarthritis.
  • Subjects with a pre-operative Knee Society Score (KSS) Knee score of >25 and <75.
  • Subjects who, in the opinion of the Investigator, can understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
  • Subjects who can give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.

Exclusion Criteria:

  • Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
  • Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
  • Subjects who have participated in a clinical study with an investigational product in the last 6 months.
  • Subjects with other significant disabling problems from the muscular-skeletal system other than in the knees (i.e.: muscular dystrophy, polio, neuropathic joints).
  • Subjects with known osteoporosis and/or previous history of fracture related to osteoporosis.
  • Subjects with a current or active history of malignancy, active or suspected infection, Paget's disease, renal osteodystrophy, immunologically suppressed, rheumatoid arthritis, sickle cell anemia, and systemic lupus erythematosus.
  • Subjects defined by the Investigator as American Society of Anesthesiologists (ASA) Grade III or IV.
  • Subjects who have a neuromuscular or neurosensory deficit.
  • Female subjects who are pregnant or lactating.
  • Subjects with an anatomical limb alignment of above 20 degrees varus or valgus.
  • Subjects with primary or secondary diagnosis of inflammatory or traumatic arthritis.
  • Subjects with a fixed flexion deformity of over 20 degrees.
  • Subjects with recurvatum (definition: hyperextension ≥ 5 degrees).
  • Subjects who have previously undergone surgery on the indicated knee including total knee arthroplasty, patellofemoral arthroplasty, or unicondylar knee arthroplasty, high tibial osteotomy, ligament reconstruction, fusion, open reduction and internal fixation.
  • Subjects that have undergone, or scheduled to undergo, contralateral total knee arthroplasty or unicondylar knee arthroplasty within ±1 year from the study surgical procedure.
  • Evidence of active or suspected (systemic or local) infection at time of surgery.

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Treatment arm utilizing primary TKA with PEEK femoral component

This study is a single arm, multi-center, prospective IDE trial. Two hundred (200) patients recruited and consented will receive the PEEK-OPTIMA™ Femoral Component and results will be compared to matched historic controls from the Maxx Orthopedics Freedom Total Knee System product registry (PK-00002 REV-01, WCG IRB# 20241890). Male and female patients 18 years of age or older with Knee Society Score (KSS) of >25 and <75 will be eligible for enrollment.

Interventions

Total Knee Arthroplasty

Primary Total Knee Arthroplasty with a PEEK femoral component

Primary outcome measure

  • Original Knee Society Score [ Time Frame: 24 months post-treatment. ]

Central Contacts and Locations

Central contacts

Nach Dave, M.S., R.Ph.

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

Corey Perine, BS, MBA

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

Locations

Ascentis

Recruiting

Leawood, Kansas, United States, 66211

South Texas Bone and Joint

Recruiting

San Antonio, Texas, United States, 78249

More Information

Sponsor

Maxx Orthopedics Inc

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • Total Knee Replacement
  • Total Knee Arthroplasty
  • Polyether-ether-ketone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Maxx Orthopedics Inc on 2026-06-26.