Evaluate the Safety, Functionality, and the Quality of Life of Patients Who Receive the Freedom Total Knee ® System

NCT02056470 | Completed

• 1 other identifier: MO-U-101A
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

Assess the safety and functionality of the Freedom Knee® system through a multi-center clinical trial. Study endpoints include a comparison of Pre-Surgery versus Post-Surgery data for:

1. 1.Range of Motion
2. 2.Quality of Life measurements using Knee Society Scale (KSS)
3. 3.Survivorship as defined by 'No Revision' of baseline implant
4. 4.Quality of Life measurements using the WOMAC Score

Conditions

Knee Joint Pain

Outcome Measures

Primary Outcomes (1)

• Assess the safety and functionality of the Freedom Knee® system through a multi-center clinical trial

  The study is hoping to assess the safety of the implant by looking at the incident of revisions to the implant post surgery up to and including 3 years

  3 years

Study Arms (1)

Freedom Total Knee Replacement

EXPERIMENTAL

Freedom Total Knee

Device: Freedom Total Knee; Device: Total Knee Replacement; Device: Freedom Total Knee System

Interventions

Freedom Total Knee DEVICE

The Freedom Total Knee System is being implanted in subjects suitable for a total knee replacement

Also known as: Freedom Total Knee System

Freedom Total Knee Replacement

Total Knee Replacement DEVICE

total Knee replacement implant

Also known as: Freedom Knee

Freedom Total Knee Replacement

Freedom Total Knee System DEVICE

Total Knee replacement implant

Also known as: Freedom Knee

Freedom Total Knee Replacement

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and Females 40-80 years of age
• Patients requiring knee prosthesis, and have been evaluated as appropriate candidates for aTKA by their orthopedic surgeon
• 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

You may not qualify if:

• Previous major 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, nueropathic joints)
• Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI \> 35)
• Patients who are found to be non-compliant by their physician
• Patients with or having; malignancy - active malignancy, active or suspected 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

Sponsors & Collaborators

• Maxx Orthopedics Inc: lead

Study Sites (1)

Maxx Ortho

Norristown, Pennsylvania, 19403, United States

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

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

Study Officials

• Robert W Eberle

  Director, Clinical Affairs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2014
• First Posted: February 6, 2014
• Study Start: September 1, 2013
• Primary Completion: February 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 30, 2020

Record last verified: 2020-03

Locations

US (1)