Maxx Orthopedics' PCK Revision TKA Study of Component Survivorship

NCT03312088 | Unknown DMC FDA Device

• 1 other identifier: MO-2017-PCK
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this clinical investigation are to evaluate the safety and performance of the Freedom Total Knee® PCK System.

Conditions

Aseptic Loosening; Infection; Bone Loss; MCL - Medial Collateral Ligament Rupture of the Knee; Periprosthetic Fractures

Outcome Measures

Primary Outcomes (1)

• Survivorship

  "No Explants"

  36 months

Secondary Outcomes (5)

• Revision rates of any component (including insert) for any reason.

  36 months

• Revision rates of any component (including insert) for any reason except infection.

  36 months

• KSS

  36 months

• WOMAC

  36 months

• ROM

  36 months

Interventions

Freedom Knee PCK Components DEVICE

Total Knee Revision

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients having undergone a primary TKR and are candidates for a revision surgery based on aseptic loosening, infections, bone loss, MCL disruption, and/or periprosthetic fractures.

You may qualify if:

• Male and female subjects aged 40 years of age or older and less than 80 years of age (\>40 and \<80 years).
• Patients having undergone a primary TKR and are candidates for a revision surgery based on aseptic loosening, infections, bone loss, MCL disruption, and/or periprosthetic fractures.
• Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and the prescribed rehabilitation.
• Subjects who, in the opinion of the Investigator, are able to 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 are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.

You may not qualify if:

• Primary knee replacement of the affected knee joint
• Other significant disabling problems from the muscular-skeletal system than in the knees (i.e muscular dystrophy, polio, neuropathic joints)
• Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living.
• Patients who are found to be non-compliant by their physician
• Patients with or having; malignancy - active malignancy, active or suspected systemic infection, Paget's disease, renal osteodystrophy, immunologically suppressed, sickle cell anemia, and systemic lupus erythmatosus.
• The patient has a neuromuscular or neurosensory deficit.
• Female patients planning a pregnancy during the course of the study.
• Patients, who are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.
• Varus or valgus deformity \> 20 degrees
• Bilateral TKR

Sponsors & Collaborators

• Maxx Orthopedics Inc: lead

Study Sites (1)

Coastal Orthopedics

Bradenton, Florida, 34209, United States

RECRUITING

MeSH Terms

Conditions

Infections; Bone Diseases, Metabolic; Periprosthetic Fractures

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fractures, Bone; Wounds and Injuries

Study Officials

• David Cashin, MD

  Coastal Orthopedics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Eberle

CONTACT

+1 (919) 280-6900; robert.eberle@maxxortho.com

Coreyn Perine

CONTACT

+1 (484) 342-0092; corey.perine@maxxortho.com

Study Design

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

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 17, 2017
• Study Start: January 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: July 15, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)