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

Knee Joint Pain Clinical Trial

Official title:

A Prospective, Multicenter, Single Arm Adaptive-Design Study to Evaluate the Safety, Functionality, and the Quality of Life of Patients Who Receive the Freedom Total Knee ® System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056470
• Other study ID #: MO-U-101A
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: March 2020

Study information

• Verified date: March 2020
• Source: Maxx Orthopedics Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. Range of Motion

2. Quality of Life measurements using Knee Society Scale (KSS)

3. Survivorship as defined by 'No Revision' of baseline implant

4. Quality of Life measurements using the WOMAC Score

Description:

The clinical study will involve a series of evaluations performed by your surgeon. These examinations are consistent with the normal surgeon care as part of Total Knee Replacement surgery. The study objective is to assess the safety, functionality, and survivorship of the Freedom Knee System through a multi-center clinical trial. Study endpoints include a comparison of Pre-Surgery (baseline) versus Post-Surgery data for Range of Motion and Flexion, Quality of Life (KSS), and survivorship (defined by 'no revisions'). Additionally, the structural integrity will be evaluated based on the x-ray performed 36-months after knee replacement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: March 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Arthralgia
• Knee Joint Pain

Intervention

Device:
• Freedom Total Knee
The Freedom Total Knee System is being implanted in subjects suitable for a total knee replacement
• Total Knee Replacement
total Knee replacement implant
• Freedom Total Knee System
Total Knee replacement implant

Locations

Country	Name	City	State
United States	Maxx Ortho	Norristown	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Maxx Orthopedics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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