- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03037242
Outcomes of Meniscus Root Repair Using a Transtibial Pullout Technique
Multi-Center Prospective Clinical and Radiographic Outcomes of Meniscus Root Repair Using a Transtibial Pullout Technique
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The loss of attachment at the root of the meniscus impairs the ability to maintain hoop strain when the tibiofemoral joint is loaded. This loss of hoop strain is responsible for the increased pressure on the articular cartilage.
This new awareness has prompted surgeons to consider surgical repair for treatment of meniscal root avulsions. Despite this recent focus on results of surgical repair, prospective studies are lacking, and the optimal surgical indications and technique have not been optimized.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Missouri
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Columbia, Missouri, United States, 65201
- Columbia Orthopaedic Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Meniscus root avulsion tear (defined as meniscus posterior horn root avulsion or full thickness tear within 9 mm of the root attachment)
- Age 18-65
- Ligament injury with concomitant reconstruction is acceptable
- Malalignment with corrective osteotomy is acceptable
Exclusion Criteria:
- Subchondral collapse on pre-op MRI
- Extrusion greater than 3 mm
- Intra-op Outerbridge grade 3 or greater chondromalacia
- Intra-op poor quality meniscus tissue
- Mal-alignment greater than 5 degrees without corrective osteotomy
- Obesity with BMI over 40
- Kellgren Lawrence > grade 2
- Worker's compensation status
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Transtibial pullout technique
Evaluation of the clinical and radiographic outcomes for patients undergoing a meniscus root repair (MRR) using a transtibial pullout technique.
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Evaluating radographs
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Tegner activity score
Time Frame: baseline, 2 years
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Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. The score varies from 0-10. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports >6 score can only be achieved if the person participates in recreational or competitive sport. |
baseline, 2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Saris, MD, Mayo Clinic
Publications and helpful links
General Publications
- Krych AJ, Song BM, Nauert RF 3rd, Cook CS, Levy BA, Camp CL, Stuart MJ, Smith PA. Prospective Consecutive Clinical Outcomes After Transtibial Root Repair for Posterior Meniscal Root Tears: A Multicenter Study. Orthop J Sports Med. 2022 Feb 24;10(2):23259671221079794. doi: 10.1177/23259671221079794. eCollection 2022 Feb.
- Krych AJ, Nauert RF 3rd, Song BM, Cook CS, Johnson AC, Smith PA, Stuart MJ. Association Between Transtibial Meniscus Root Repair and Rate of Meniscal Healing and Extrusion on Postoperative Magnetic Resonance Imaging: A Prospective Multicenter Study. Orthop J Sports Med. 2021 Aug 16;9(8):23259671211023774. doi: 10.1177/23259671211023774. eCollection 2021 Aug.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 16-005841
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Transtibial pullout technique
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Al-Azhar UniversityCompletedPosterior Root Tear of the Medial Meniscus | Arthroscopic Transtibial Pullout Suture Repair | Suture Anchor RepairEgypt
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Eastern Mediterranean UniversityCompletedQuality of Life | Amputation | Fall | Prosthesis User | Ambulation DifficultyTurkey
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University of PennsylvaniaNational Institute on Aging (NIA); iFIT Prosthetics, LLCCompletedAmputationUnited States
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Massachusetts Institute of TechnologyIntegrum; Brigham and Women's HospitalRecruiting
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Massachusetts Institute of TechnologyNational Institute for Biomedical Imaging and Bioengineering (NIBIB)CompletedAmputation StumpUnited States, Mexico
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Hacettepe UniversityNot yet recruitingQuality of Life | Amputation | Balance | Muscle Activation | Sense of ControlTurkey
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Brigham and Women's HospitalIntegrum; Massachusetts Institute of Technology (MIT)Active, not recruiting