Clinical trial NCT02362867: Balanced Knee System Clinical Protocol for IRB Approval
Official title: Balanced Knee System Clinical Protocol for IRB Approval
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Rheumatoid Arthritis of Knee
Post-traumatic Osteoarthritis of Knee Nos
Valgus Deformity
Lead sponsor: Ortho Development Corporation
Sponsor class: INDUSTRY
Collaborators: name: St. Mark's Hospital
name: Salt Lake Orthopaedic Clinic
First posted: 2015-02-13
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The protocol will define the clinical study for Ortho Development's Balanced Knee® System (BKS) for subsequent review and approval by an Institutional Review Board (IRB).This clinical study will compare the clinical outcomes of BKS to currently marketed devices.

Detailed description: The rationale is based on the potential effectiveness of the BKS to:

* Return patient to normal activities or increase mobility by restoring knee function.
* Provide stability to enhance rehabilitation without external support.
* Eliminate or reduce knee pain.
* Assess the clinical efficacy after total knee replacement.
* Determine implant survivorship and viability.
* Evaluate patient function and satisfaction.

Eligibility criteria: Inclusion Criteria:

* Loss of joint configuration and joint function.
* Osteoarthritis of the knee joint.
* Rheumatoid arthritis of the knee joint.
* Post-traumatic arthritis of the knee joint.
* Moderate valgus, varus, or flexion deformities.

Exclusion Criteria:

* Any patient not experiencing a compromised quality of life by loss of joint function and/or joint configuration, or pain from arthritis disease.
* Any patient whose knee cannot be returned to normal function and normal stability through reconstructive procedures, including ligamentous balancing.
* Active infection in or near the knee joint, fever and/or local inflammation signs, and elevation of sedimentation rate unexplained by other diseases should not be treated unless preoperative infection is ruled out.
* Distant foci of infection, such as genitourinary, pulmonary, skin (chronic lesions or ulcerations), and other sites, which may result in hematogenous spread to the implant site.
* Rapid joint destruction or bone absorption apparent on roentgenograms.
* Neuromuscular disorders in which the potentially adverse effects on prosthesis function are not outweighed by the benefits gained by the patient from usage of the prosthesis.
* Mental disorders which would compromise essential patient post-operative care.
* A painless, stable arthrodesis in a functional position.
* Allergic reactions to implant materials, and/or tissue reactions to the products of corrosion or wear.
* Skeletal immaturity.
* Any patient who is unwilling or unable to comply with post-operative instructions or clinical study requirements.

Primary outcomes:
measure: Evaluate effectiveness of the BKS by assessing complications during surgery and the post-operative follow-up period
timeFrame: 1-10 years
Secondary outcomes:
measure: Assess the effectiveness of the BKS by analyzing radiographic evidence and clinical data.
timeFrame: 1-10 years
measure: Identify any surveillance issues regarding the device design and surgical approach used refinement of the surgical technique
timeFrame: 1-10 years
measure: Evaluate device performance through the use of the Knee Society Score, Short Form-36 Health Survey, and radiographic evaluation.
timeFrame: 1-10 years
Other outcomes:
Locations:
Study officials:
affiliation: Salt Lake Orthopaedic Clinic
name: Michael H. Bourne, M.D.
role: PRINCIPAL_INVESTIGATOR
References: