Clinical trial NCT02056470: Evaluate the Safety, Functionality, and the Quality of Life of Patients Who Receive the Freedom Total Knee ® System
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Joint Pain
Lead sponsor: Maxx Orthopedics Inc
Sponsor class: INDUSTRY
First posted: 2014-02-06
Enrollment: 211
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess the safety and functionality of the Freedom Knee® system through a multi-center clinical trial
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Norristown
country: United States
facility: Maxx Ortho
state: Pennsylvania
Study officials:
affiliation: Director, Clinical Affairs
name: Robert W Eberle
role: STUDY_DIRECTOR
References: