Anterior Cruciate Ligament RuptureNCT01450332
Safety and Efficacy of the Knee-T-nol Anterior Cruciate Ligament (ACL) Prosthesis
A study testing Knee-T-Nol in people with Anterior Cruciate Ligament Rupture, run by Tavor Ltd. at 1 site in Israel.
Trial summary
The study is designed to evaluate the safety and efficacy of implanting the Tavor ACL prosthesis in patients with a ruptured ACL by improvement of healing kinetics as well as major adverse treatment events (AEs). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- Knee-T-Nol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2011to Jan 2013
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is >= 18 years old
- Patient has a ruptured ACL
- Operated knee has full range of motion and no swelling
- Patient understands the study requirements and the treatment procedures and rehabilitation and provides written Informed Consent before any study-specific tests or procedures are performed.
- The patient commits to fully undergo the rehabilitation program and return for the scheduled post-operative follow-up visits at the clinic.
Who cannot join
- Skeletal immaturity
- Pregnancy
- Patient with:
- Uncontrolled systemic hypertension
- Severe uncontrolled Diabetes Mellitus
- Epiphyses That Have Not Yet Closed
Show all 16Show fewer
- Periarticular or Patella Fracture
- History of Metabolic Bone Disease (e.g.., Osteoporosis, Rickets)
- Crystal deposition disease, e.g., gout
- Inflammatory joint disease, e.g., rheumatoid arthritis
- Severe degenerative joint disease
- Known neoplastic disease
- HIV positive
- Current steroid therapy in excess of prednisone 5 mg/day
- Other severe, life-threatening systemic disease or any medical condition that interferes with their ability to participate in a rehabilitation program
- The subject has participated in, or is planned to participate in, any investigational drug or device study within the past 30 days and for the duration of this study.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Shhare Zedek Medical Center
Jerusalem, Israel, 91031
Yoram Litwin, MD
About this study
Official title: A Single Arm, Prospective, Single Center, Study To Evaluate The Safety And Efficacy Of Tavor ACL Prosthesis In Patient With ACL Rupture
The study is designed to evaluate the safety and efficacy of implanting the Tavor ACL prosthesis in patients with a ruptured ACL by improvement of healing kinetics as well as major adverse treatment events (AEs). it is designed to test the hypothesis that there is a difference in healing kinetics of ACL deficient knees treated by ACL reconstruction using autografts and those in which such procedure was performed with the Tavor prosthesis.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- Knee-T-Nol
- Keywords
- ACL, arthroscopy, ligament, rupture, reconstruction, ACLR, accelerated rehabilitation program
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee-T-NolDevice
The ACL prosthesis is intended for the treatment of ruptured ACL. It will be used as an implant to replace the native, torn ACL. Implantation will be done using arthroscopy
| Study group | Role | What they receive |
|---|---|---|
| study | Experimental | Not described Receives: Device: Knee-T-Nol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee stability, as measured by a KT-1000 Arthrometer or Lachman test post procedure
Measured: post procedure
No treatment emergent SAEs, including Adverse Events of Interest (AEOI), 3 months post procedure.
Measured: 3 months post procedure
Secondary outcomes (3)
Rehabilitation period, defined by Post procedure period [weeks] to successful rehabilitation phase
Rehabilitation period, defined by Post procedure period [weeks] to successful rehabilitation phase, as demonstrated by the ability of the patient to perform the following functional tests:
- 70% of single leg 1 Rep Max on leg press vs. uninvolved
- 10 single leg squats from 0-45° of flexion without loss of balance, muscle quivering, or varus/valgus moments (patella moving out of the sagittal plane)
- 30 consecutive forward step-and-holds from the uninvolved to involved leg without loss of balance, muscle quivering, or varus/valgus moments (patella moving out of the sagittal plane)
Measured: 3-6 months
Tegner Lysholm scores during the followup period
Short term Tegner Lysholm knee score >= 65, 3 months post procedure. Long term Knee stability, as measured by a KT-1000 Arthrometer or Lachman test at 12 months post procedure.
Long term Tegner Lysholm knee score >= 84, 12 months post procedure. Procedure time, as compared to standard autograft procedure
Measured: 12 months post op
Long term safety: no device related SAEs 12 months post procedure.
Measured: 12 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tavor Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Idan M Tobis, B.Sc., Study director, Tavor Ltd.Yoram Litwin, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450332
- Sponsor's protocol ID
- TACLPPS01 Rev 4
- Status last verified
- Oct 2011
- First submitted
- 9 Oct 2011
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Prospective, Single Center, Study To Evaluate The Safety And Efficacy Of Tavor ACL Prosthesis In Patient With ACL Rupture
- ClinicalTrials.gov ID
- NCT01450332
- Acronym / sponsor ID
- TACLPPS01 Rev 4
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- ACL, arthroscopy, ligament, rupture, reconstruction, ACLR, accelerated rehabilitation program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tavor Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 12 Oct 2011 (estimated)
- 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.
The study is designed to evaluate the safety and efficacy of implanting the Tavor ACL prosthesis in patients with a ruptured ACL by improvement of healing kinetics as well as major adverse treatment events (AEs). it is designed to test the hypothesis that there is a difference in healing kinetics of ACL deficient knees treated by ACL reconstruction using autografts and those in which such procedure was performed with the Tavor prosthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study | Experimental | Device: Knee-T-Nol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is >= 18 years old
- Patient has a ruptured ACL
- Operated knee has full range of motion and no swelling
- Patient understands the study requirements and the treatment procedures and rehabilitation and provides written Informed Consent before any study-specific tests or procedures are performed.
- The patient commits to fully undergo the rehabilitation program and return for the scheduled post-operative follow-up visits at the clinic.
Key exclusion criteria (16 listed)
- Skeletal immaturity
- Pregnancy
- Patient with:
- The subject has participated in, or is planned to participate in, any investigational drug or device study within the past 30 days and for the duration of this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knee-T-NolThe ACL prosthesis is intended for the treatment of ruptured ACL. It will be used as an implant to replace the native, torn ACL. Implantation will be done using arthroscopy | Device | study |
Primary outcome
Knee stability, as measured by a KT-1000 Arthrometer or Lachman test post procedure
Time frame: post procedure
No treatment emergent SAEs, including Adverse Events of Interest (AEOI), 3 months post procedure.
Time frame: 3 months post procedure
3 secondary outcomes
Rehabilitation period, defined by Post procedure period [weeks] to successful rehabilitation phase
Time frame: 3-6 months
Tegner Lysholm scores during the followup period
Time frame: 12 months post op
Long term safety: no device related SAEs 12 months post procedure.
Time frame: 12 months post op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
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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.
Idan M Tobis, B.Sc. study director
Tavor Ltd.
Yoram Litwin, MD principal investigator
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee-T-Nol in people with Anterior Cruciate Ligament Rupture, run by Tavor Ltd. at 1 site in Israel.
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 5 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan S Yalom, B.Sc. (+972-9-7733910, jonathan@tavormed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee stability, as measured by a KT-1000 Arthrometer or Lachman test post procedure (time frame: post procedure). The study lists 2 primary outcomes in all. 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 12 Oct 2011.