ACL RepairNCT03519555
BIOSURE™ RG Knee Safety & Performance Study
An observational study of ACL Repair and Posterior Cruciate Ligament (PCL) Repair, run by Smith & Nephew, Inc. at 3 sites in United States.
Trial summary
Safety and Performance of the BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACL Repair, Posterior Cruciate Ligament (PCL) Repair, Medial Collateral Ligament (MCL)
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Nov 2017to 5 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects who have received BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction. This population will be used for safety analysis.
Who may be able to join
- Subject has provided informed consent for study participation.
- Subject is eighteen (18) years of age or older at the time of enrollment in the study.
- Subject requires one of the following knee procedures:
- Anterior cruciate ligament (ACL) repair
- Posterior cruciate ligament (PCL) repair
- Extra-capsular repair - Medial collateral ligament (MCL), Lateral collateral ligament (LCL), Posterior oblique ligament (POL)
- Patellar realignment and tendon repair Vastus medialis obliquus advancement Iliotibial band tenodesis
- Subject is willing and able to comply with study visit schedule and to complete study procedures and questionnaires.
Who cannot join
- Subject has Body Mass Index (BMI) > 40.
- Subject has had total knee arthroplasty (TKA) in the study knee.
- Subject has conditions that may interfere with graft survival or outcome (e.g. Paget disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).
- Subject has a known allergy to the study device or any of its components.
- Subject, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their willingness to participate in the study, including mental illness, mental retardation, drug or alcohol abuse, subject is pregnant, or plans to become pregnant during the study.
- Subject is entered in another investigational drug, biologic, or device study, or has been treated with an investigational product in the past 30 days.
- Subject is known to be at risk for loss to follow-up or failure to return for scheduled visits.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, 28207
Kelsey-Seybold Clinic/ Kelsey Research Foundation
Houston, Texas, 77025
OrthoIllinois
Rockford, Illinois, 61107
About this study
Official title: Safety and Performance of the BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction
Safety and Performance of the BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction
Read the detailed description
This post-market clinical follow-up (PMCF) study will prospectively evaluate the short-term (6- and 12-month) safety and performance of the BIOSURE REGENESORB Interference Screw when used for any of the following:
Knee repair:
- ACL repair Posterior cruciate ligament (PCL) repair
- Extra-capsular repairs
- Medial collateral ligament (MCL)
- Lateral collateral ligament (LCL)
- Posterior oblique ligament (POL)
- Patellar realignment and tendon repairs
- Vastus medialis obliquus advancement
- Iliotibial band tenodesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft fixation survival
Survival rate at 6 months
Measured: 6 months
Secondary outcomes (6)
Graft fixation survival
Survival rate at 12 months
Measured: 12 months
Graft survival at 6 and 12 months
where failure is defined as graft repair failure for any reason
Measured: 6 months and 12 months
Quality of Life - International Knee Documentation Committee Score
Patient Reported Outcomes using International Knee Documentation Committee Score. Scores summed and normalized to 100, minimum score is 0 points and maximum score is 100 points. The lower the score, the greater the disability.
Measured: Pre-Op, 6 months and 12 months
Quality of Life - Tegner Activity Scale
Patient Reported Outcomes using Tegner Activity Scale, subject indicates highest level of activity before injury and highest level of activity after injury. Levels on a scale from 0 to 10, with 10 being highest level.
Measured: Pre-Op, 6 months and 12 months
Quality of Life - Lysholm Score
Patient Reported Outcomes using Lysholm Score, subject will answer eight questions on how knee pain has affected everyday life. Each question will be answered by placing a checkmark that best describes current condition.
Measured: Pre-Op, 6 months and 12 months
Quality of Life - EQ-5D-5L
Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire, subject will check box describing health on mobility, self-care, usual daily activities, pain/discomfort, and anxiety/depression. There are five checkbox options for each: no problems, slight, severe, unable to do activity. Subject will indicate from a scale of 1 to 100 (100 best), how good or bad is current health.
Measured: Pre-Op, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start9 Nov 2017
- Primary completion5 Oct 2020
- Study completion5 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephan Mangin, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519555
- Sponsor's protocol ID
- 16-5010-16
- Status last verified
- Jul 2021
- First submitted
- 15 Jan 2018
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of the BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction
- ClinicalTrials.gov ID
- NCT03519555
- Acronym / sponsor ID
- 16-5010-16
- Conditions
- ACL Repair, Posterior Cruciate Ligament (PCL) Repair, Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), Posterior Oblique Ligament (POL), Patellar Realignment and Tendon Repairs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and Performance of the BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction
Detailed description
This post-market clinical follow-up (PMCF) study will prospectively evaluate the short-term (6- and 12-month) safety and performance of the BIOSURE REGENESORB Interference Screw when used for any of the following:
Knee repair:
- ACL repair Posterior cruciate ligament (PCL) repair
- Extra-capsular repairs
- Medial collateral ligament (MCL)
- Lateral collateral ligament (LCL)
- Posterior oblique ligament (POL)
- Patellar realignment and tendon repairs
- Vastus medialis obliquus advancement
- Iliotibial band tenodesis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects who have received BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction. This population will be used for safety analysis.
Key inclusion criteria (8 listed)
- Subject has provided informed consent for study participation.
- Subject is eighteen (18) years of age or older at the time of enrollment in the study.
- Subject requires one of the following knee procedures:
- Subject is willing and able to comply with study visit schedule and to complete study procedures and questionnaires.
Key exclusion criteria (7 listed)
- Subject has Body Mass Index (BMI) > 40.
- Subject has had total knee arthroplasty (TKA) in the study knee.
- Subject has conditions that may interfere with graft survival or outcome (e.g. Paget disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).
- Subject has a known allergy to the study device or any of its components.
- Subject, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their willingness to participate in the study, including mental illness, mental retardation, drug or alcohol abuse, subject is pregnant, or plans to become pregnant during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Graft fixation survival
Time frame: 6 months
Survival rate at 6 months
6 secondary outcomes
Graft fixation survival
Time frame: 12 months
Graft survival at 6 and 12 months
Time frame: 6 months and 12 months
Quality of Life - International Knee Documentation Committee Score
Time frame: Pre-Op, 6 months and 12 months
Quality of Life - Tegner Activity Scale
Time frame: Pre-Op, 6 months and 12 months
Quality of Life - Lysholm Score
Time frame: Pre-Op, 6 months and 12 months
Quality of Life - EQ-5D-5L
Time frame: Pre-Op, 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Mangin study chair
Smith & Nephew, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL Repair and Posterior Cruciate Ligament (PCL) Repair, run by Smith & Nephew, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft fixation survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.