Clinical trial NCT03037242: Outcomes of Meniscus Root Repair Using a Transtibial Pullout Technique
Official title: Multi-Center Prospective Clinical and Radiographic Outcomes of Meniscus Root Repair Using a Transtibial Pullout Technique
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Meniscus Tear
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The results of this study will optimize the care for patients with a meniscus root tear. Surgeons will be able to determine if MRR (meniscus root repair) with transtibial pullout technique is an effective treatment and will identify potential risk factors for poor clinical outcomes. In addition, investigators will determine if MRR is successful in delaying the radiographic progression of arthritis in the involved compartment.

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.

Eligibility criteria: Inclusion Criteria:

1. Meniscus root avulsion tear (defined as meniscus posterior horn root avulsion or full thickness tear within 9 mm of the root attachment)
2. Age 18-65
3. Ligament injury with concomitant reconstruction is acceptable
4. Malalignment with corrective osteotomy is acceptable

Exclusion Criteria:

1. Subchondral collapse on pre-op MRI
2. Extrusion greater than 3 mm
3. Intra-op Outerbridge grade 3 or greater chondromalacia
4. Intra-op poor quality meniscus tissue
5. Mal-alignment greater than 5 degrees without corrective osteotomy
6. Obesity with BMI over 40
7. Kellgren Lawrence \> grade 2
8. Worker's compensation status

Primary outcomes:
measure: Change in Tegner activity score
timeFrame: baseline, 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Columbia
country: United States
facility: Columbia Orthopaedic Group
state: Missouri
Study officials:
affiliation: Mayo Clinic
name: Daniel Saris, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.