Single arm study on Meniscal root repair implant

A Single Centre Study to Assess the Safety and Functional Outcomes after Arthroscopic Meniscal Repair using T Button R Meniscus Root Repair Implant - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/06/088141

Enrollment

Registered

2025-06-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M179- Osteoarthritis of knee, unspecified

Interventions

Intervention1: T Button R Meniscus Root Repair Implant: T Button R Meniscus Root Repair Implant is a permanently implantable Polyether Ether Ketone (PEEK) fixation device which provides the orthopae

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male/ female participants between 18 -70 years 2. Participants with meniscal root tear which requires surgical repair 3. Participants who are willing to provide written Informed Consent and comply with study procedures

Exclusion criteria

Exclusion criteria: 1. Participants with BMI more than or equal to 35 kg/m2 2. Participants who had undergone previous surgery in the same or contralateral knee 3. Participants with a history of deep vein thrombosis (DVT) 4. Participants with any condition which makes the subject unsuitable for study participation which as per the investigator would jeopardize the outcome of the trial or participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this study 5. Pregnant and lactating female at the time of screening

Design outcomes

Primary

Measure	Time frame
1.To assess functional outcomes of Knee post- meniscal root repair by measuring change in IKDC scoreTimepoint: [Time frame: Screening/ Baseline, month 1.5, month 3, month 6 and month 12]	—

Secondary

Measure	Time frame
1. To assess the clinical symptoms and activity level in the eligible subjects who will undergo meniscal root repair using T Button R Meniscus Root Repair Implant via Lysholm knee score, Tegner activity scale score, and SANE. 2. To assess the failure rate of meniscal root repair using T Button R Meniscus Root Repair Implant in the eligible subjects 3. To assess change in quality of life in patients via modified KOOS score who will undergo meniscal root repair using T Button R Meniscus Root Repair Implant. 4. To assess recovery period in patients who will undergo meniscal root repair using T Button R Meniscus Root Repair Implant 5. To assess the duration of surgery with T Button R Meniscus Root Repair Implant 6. To assess the overall intraoperative handling of T Button R Meniscus Root Repair Implant 7. To assess the safety of the T Button R Meniscus Root Repair Implant Timepoint: 1. [Time frame: Screening/ Baseline, month 1.5, month 3, month 6 and month 12] 2. [Time frame: All visits after surgery including surgery day] 3. [Time frame: Screening/ Baseline, month12] 7.[Time frame: All visits after surgery including surgery day]	—

Measure

Time frame

1. To assess the clinical symptoms and activity level in the eligible subjects who will undergo meniscal root repair using T Button R Meniscus Root Repair Implant via Lysholm knee score, Tegner activity scale score, and SANE. 2. To assess the failure rate of meniscal root repair using T Button R Meniscus Root Repair Implant in the eligible subjects 3. To assess change in quality of life in patients via modified KOOS score who will undergo meniscal root repair using T Button R Meniscus Root Repair Implant. 4. To assess recovery period in patients who will undergo meniscal root repair using T Button R Meniscus Root Repair Implant 5. To assess the duration of surgery with T Button R Meniscus Root Repair Implant 6. To assess the overall intraoperative handling of T Button R Meniscus Root Repair Implant 7. To assess the safety of the T Button R Meniscus Root Repair Implant Timepoint: 1. [Time frame: Screening/ Baseline, month 1.5, month 3, month 6 and month 12] 2. [Time frame: All visits after surgery including surgery day] 3. [Time frame: Screening/ Baseline, month12] 7.[Time frame: All visits after surgery including surgery day]

—

Countries

India

Contacts

Public ContactDr Mukesh Garg

Sarvodaya Hospital and Research Centre

mukesh_imsbhu@yahoo.com9540583068

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026