KRONOS Versus Breg T-Scope Post-operative Knee Braces Following Anterior Cruciate Ligament (ACL) Reconstruction

Conditions

• Anterior Cruciate Ligament (ACL) Reconstruction Surgery

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Arm 1-Kronos brace — DEVICE
  Subjects randomized to the treatment group will be measured and fitted with the KRONOS knee brace at their initial clinic visit after study enrollment
• Arm 2-Breg T-Scope brace — DEVICE
  Subjects randomized to Breg T-Scope Postoperative Brace will be placed in this standard postoperative hinged knee brace in the operating room that will be locked in full extension.

Study Details

The purpose of this study is to evaluate how well the KRONOS postoperative knee brace reduces pain and enhances recovery compared with the standard Breg T-scope hinged brace following anterior cruciate ligament (ACL) reconstruction knee surgery.

Key Dates

Start date

Feb 11, 2025

Status verified

Feb 2026

Primary completion

Sep 30, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: Arm 1-Kronos brace
  Subjects randomized to the treatment group will be measured and fitted with the KRONOS knee brace at their initial clinic visit after study enrollment.
• Active Comparator: Arm 2-Breg T-Scope brace
  Subjects randomized to the standard postoperative Breg T-Scope hinged knee brace in the operating room that will be locked in full extension.

Primary Outcome Measure

Rates of extension deficit [ Time Frame: 1 year post-operative ]

Central Contacts

• Adam Yanke, MD PhD
  (312) 432-2818
  [email protected]

Locations (1)

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