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Prosthetic Knee

Reboocon Intuy Knee for Amputation

N/A

Recruiting

Led By Jennifer Johansson, MS

Research Sponsored by Liberating Technologies, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are at least 18 years old

Transfemoral prosthesis user (limb absence between the knee and hip)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start of study (0 months), 3 months, 6 months, 9 months

Awards & highlights

Study Summary

This trial aims to collect data from people with above-the-knee amputations to help doctors choose the best powered prosthetic knee for each patient. The data will be used to guide the prescription of

Who is the study for?

This trial is for individuals with above-knee amputations, specifically K2-level transfemoral amputees. It's aimed at those who use prosthetic knees and are looking to improve their mobility. The study excludes certain groups based on specific criteria not provided here.Check my eligibility

What is being tested?

The study compares non-powered (Reboocon Intuy Knee) versus powered (Ossur Power Knee) prosthetic knees in people with leg amputations. It aims to determine which device offers the most benefit in real-world settings outside of a lab environment.See study design

What are the potential side effects?

While specific side effects are not listed, potential issues may include discomfort, skin irritation, or difficulty adapting to the new prosthesis. More details would be needed for a comprehensive list.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I use a prosthetic leg that fits between my knee and hip.

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My weight is between 110lbs and 256lbs.

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I have used a prosthesis for at least six months.

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I wear a prosthesis for most of the week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of study (0 months), 3 months, 6 months, 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start of study (0 months), 3 months, 6 months, 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and start of study (0 months), 3 months, 6 months, 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Activities-Specific Balance Confidence scale (ABC) - Measuring change from baseline

Prosthesis Evaluation Questionnaire - Well Being (PEQ-WB) - Measuring change from baseline

Step count

Secondary outcome measures

Borg Rating of Perceived Exertion (Borg RPE)

Oswestry Disability Index (ODI)

Patient Reported Outcomes Measures Information System - 29 (PROMIS-29)

+8 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Reboocon Intuy KneeExperimental Treatment1 Intervention

The subject will wear the Reboocon Intuy Knee for 3 months, as well as in the lab to complete outcome measures.

Group II: Ossur Power KneeExperimental Treatment1 Intervention

The subject will wear the Ossur Power Knee for 3 months, as well as in the lab to complete outcome measures.

Group III: Comparator BaselineActive Control1 Intervention

The subject will wear the Ossur OFM-2, a passive mechanical knee which is the most commonly used knee for K2 users, for 3 months, as well as in the lab to complete outcome measures.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Liberating Technologies, Inc.Lead Sponsor

11 Previous Clinical Trials

71 Total Patients Enrolled

Hanger Clinic: Prosthetics & OrthoticsOTHER

9 Previous Clinical Trials

369 Total Patients Enrolled

Jennifer Johansson, MSPrincipal InvestigatorLiberating Technologies, Inc.

1 Previous Clinical Trials

12 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for patients to participate in this trial?

"Indeed, according to the information provided on clinicaltrials.gov, this trial is presently seeking eligible participants. The initial posting of the study occurred on September 12th, 2023, and it was most recently updated on December 22nd, 2023."

Answered by AI

What is the current number of individuals enrolled in this medical study?

"Indeed, the information available on clinicaltrials.gov confirms that this study is actively seeking eligible participants. The trial was initially posted on September 12th, 2023 and underwent its most recent update on December 22nd, 2023. A total of 26 patients will be enrolled from a single designated site."

Answered by AI

What are the specific objectives of this research study?

"The primary outcome measure for this clinical trial is the Activities-Specific Balance Confidence scale (ABC), which will be used to assess changes from baseline over the entire 9-month study period. Secondary outcomes include the Stair Assessment Index (SAI), a 14-level ordinal scale that evaluates an individual's ability to ascend and descend stairs, as well as the Timed Up and Go Test (TUG), which measures physical mobility by timing how long it takes for participants to rise from a chair, walk to a marker, turn around, return, and sit back down. Additionally, Patient Reported Outcomes Measures Information System - Physical Function (P"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees

Jennifer Johansson 2023. "Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06194838.

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