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Balanced Knee System Clinical Protocol for IRB Approval

Primary Purpose

Osteoarthritis, Knee, Rheumatoid Arthritis of Knee, Post-traumatic Osteoarthritis of Knee Nos

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Balanced Knee System

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

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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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Total Knee Replacement

Arm Description

Total knee replacement is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to degenerative bone disease such as osteoarthritis, rheumatoid arthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyles, or complications from a previous prosthesis. The Balanced Knee System (BKS) will be used to treat patients undergoing a total knee replacement.

Outcomes

Primary Outcome Measures

Evaluate effectiveness of the BKS by assessing complications during surgery and the post-operative follow-up period

Secondary Outcome Measures

Assess the effectiveness of the BKS by analyzing radiographic evidence and clinical data.

Identify any surveillance issues regarding the device design and surgical approach used refinement of the surgical technique

Evaluate device performance through the use of the Knee Society Score, Short Form-36 Health Survey, and radiographic evaluation.

Full Information

NCT ID

NCT02362867

First Posted

February 9, 2015

Last Updated

September 23, 2021

Sponsor

Ortho Development Corporation

Collaborators

St. Mark's Hospital, Salt Lake Orthopaedic Clinic

1. Study Identification

Unique Protocol Identification Number

NCT02362867

Brief Title

Balanced Knee System Clinical Protocol for IRB Approval

Official Title

Balanced Knee System Clinical Protocol for IRB Approval

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

January 2003 (Actual)

Primary Completion Date

June 2, 2019 (Actual)

Study Completion Date

June 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ortho Development Corporation

Collaborators

St. Mark's Hospital, Salt Lake Orthopaedic Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee, Rheumatoid Arthritis of Knee, Post-traumatic Osteoarthritis of Knee Nos, Valgus Deformity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

500 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Total Knee Replacement

Arm Type

No Intervention

Arm Description

Intervention Type

Device

Intervention Name(s)

Balanced Knee System

Other Intervention Name(s)

BKS

Intervention Description

A multi-compartmental total knee replacement providing a system of components for primary posterior cruciate ligament substituting procedures. The system consists of femoral, tibial, and patellar components that allow the surgeon to select the most appropriate component combination to meet specific patient needs.

Primary Outcome Measure Information:

Title

Evaluate effectiveness of the BKS by assessing complications during surgery and the post-operative follow-up period

Time Frame

1-10 years

Secondary Outcome Measure Information:

Title

Assess the effectiveness of the BKS by analyzing radiographic evidence and clinical data.

Time Frame

1-10 years

Title

Identify any surveillance issues regarding the device design and surgical approach used refinement of the surgical technique

Time Frame

1-10 years

Title

Evaluate device performance through the use of the Knee Society Score, Short Form-36 Health Survey, and radiographic evaluation.

Time Frame

1-10 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael H. Bourne, M.D.

Organizational Affiliation

Salt Lake Orthopaedic Clinic

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Balanced Knee System Clinical Protocol for IRB Approval

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