The Rehabilitative Functional Hinged Knee Brace is an innovative device designed to support individuals with knee instability resulting from injuries, surgeries, or degenerative conditions like osteoarthritis. This dossier outlines the product's key features, target market, clinical relevance, and evaluation criteria.
This knee brace integrates advanced design elements to enhance mobility, comfort, and durability. Key features include:

• Polycentric Hinges: mimic natural knee movement, allowing safe flexion and extension while controlling lateral and rotational motion.
• Lightweight Materials: constructed from carbon fibre and aluminium, ensuring robustness without compromising comfort.
• Adjustable Strapping System: provides a custom fit for even load distribution across the knee joint, enhancing stability and reducing pain.
• Compression Mechanism: promotes blood flow and reduces swelling through strategically placed straps, aiding in recovery post-injury or surgery.

Target Market
The primary users of the knee brace include:

• Athletes: Individuals recovering from ligament injuries such as ACL and MCL tears who require stabilisation to return to high-impact sports safely.
• Elderly Population: Those suffering from osteoarthritis or other degenerative conditions that impair mobility and daily activities.
• Post-Surgical Patients: Individuals recovering from knee surgeries that need controlled movement to protect surgical grafts and facilitate healing.

Clinical Need
The knee is the largest joint in the human body and is susceptible to various injuries. With over 100,000 ACL injuries reported annually in the USA alone, there is a significant demand for effective rehabilitation tools. The proposed knee brace addresses this need by providing:

• Enhanced stability to reduce pain during movement.
• Support for rehabilitation processes following ligament injuries or surgeries.
• A non-invasive treatment option for managing chronic conditions like osteoarthritis.

Evaluation Criteria
To ensure the knee brace meets safety and performance standards, several evaluations will be conducted:
1. Structural Integrity Assessment: tests will measure stress levels at critical points to ensure they remain within safe limits.
2. Load-Bearing Capacity: displacement and strain evaluations will verify the brace's ability to support loads during various movements.
3. Material Verification: ensures that material properties align with specifications for strength and elasticity.
4. Simulation Fidelity: mesh quality will be assessed to confirm accurate simulation results for stress and strain distributions.