NCT03037242

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
May 2017Feb 2027

First Submitted

Initial submission to the registry

January 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

9.7 years

First QC Date

January 26, 2017

Last Update Submit

January 5, 2026

Conditions

Meniscus Tear

Outcome Measures

Primary Outcomes (1)

  • Change in Tegner activity score

    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

Study Arms (1)

Transtibial pullout technique

OTHER

Evaluation of the clinical and radiographic outcomes for patients undergoing a meniscus root repair (MRR) using a transtibial pullout technique.

Procedure: Transtibial pullout technique

Interventions

Transtibial pullout techniquePROCEDURE

Evaluating radographs

Transtibial pullout technique

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Columbia Orthopaedic Group

Columbia, Missouri, 65201, United States

Location

Related Publications (2)

  • 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: 35237699DERIVED

  • 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: 34423058DERIVED

Related Links

Study Officials

  • Daniel Saris, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Orthopedics

Study Record Dates

First Submitted

January 26, 2017

First Posted

January 31, 2017

Study Start

May 1, 2017

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)