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Enrolling by invitation NCT03037242

Outcomes of Meniscus Root Repair Using a Transtibial Pullout Technique

No phase Interventional Meniscus Tear

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transtibial pullout technique.
Who it may be relevant to
Registry conditions: Meniscus Tear. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Multi-Center Prospective Clinical and Radiographic Outcomes of Meniscus Root Repair Using a Transtibial Pullout Technique

Overview

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.

Interventions

  • Procedure Transtibial pullout technique
    Evaluating radographs

Primary outcome measures

  • Change in Tegner activity score [Time frame: baseline, 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Mayo Clinic — Rochester
  • Columbia Orthopaedic Group — Columbia

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. PMID 35237699
  • 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. PMID 34423058

Identifiers

NCT: NCT03037242 · 16-005841

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗