Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT02362867
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.
Study:
NCT02362867
Study Brief:
Protocol Section:
NCT02362867