KRONOS Versus Breg T-Scope Post-operative Knee Braces Following Anterior Cruciate Ligament (ACL) Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRush University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects > 18 years of age
English-speaking
Scheduled to undergo primary anterior cruciate ligament reconstruction surgery
No history of prior knee surgery on the operative knee
Disqualifiers
Age < 18 years of age
Non-English speaking
Revision ACL reconstruction
Multi-ligamentous injury, including concomitant posterior cruciate ligament, medial collateral ligament and fibular collateral ligament injuries
Trial design
Design model
Parallel
Treatments tested in this trial
Arm 1-Kronos brace
DeviceSubjects 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
DeviceSubjects 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Arm 1-Kronos braceExperimental treatment 1 intervention
Group B: Arm 2-Breg T-Scope braceActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rates of extension deficit
Rates of extension deficit (as measured by the fraction of patients with reduced extension compared to the contralateral determined by heel height and goniometric measurements of knee extension (cm/ degrees)
Time frame
1 year post-operativeSponsors and contacts
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Source ClinicalTrials.gov