To assess the Safety and Functional outcomes of Adjustable Loop Suture Button and PEEK Interference Screw during Arthroscopic ACL Reconstruction

A Single Centre Study to Assess the Safety and Functional Outcomes after Arthroscopic Anterior Cruciate Ligament- ACL Reconstruction Procedure Using Adjustable Loop Suture Button and PEEK Interference Screw - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100412

Enrollment

Registered

2026-01-06

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: M708- Other soft tissue disorders related to use, overuse and pressure

Interventions

Intervention1: Adjustable Loop Suture Button: Adjustable Loop Suture Button is used for femoral fixation during ACLR procedure Duration: Permanent implant Control Intervention1: PEEK interference scre

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or female participants between 18 years and 45 years of age at the time of consent 2.Participants with traumatic ACL tears with or without associated meniscus injuries requiring primary ACL reconstruction surgery 3.Participants and or Legally Acceptable Representative who are willing to provide written Informed Consent and comply with study procedures

Exclusion criteria

Exclusion criteria: 1.Participants with lateral/medial collateral ligament injury or posterior cruciate ligament injury. 2.Participants with BMI gretaer than or equal to 35 kg m2 3.Participants who had undergone previous surgery in the same or contralateral knee 4.Participants with a history of deep vein thrombosis (DVT) 5.Participants with arthritis of same or contralateral knee 6.Participants with any condition which makes the subject unsuitable for study participation which as per the investigator would jeopardize the outcome of thetrial or participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this clinical investigation plan 7.Pregnant and lactating female at the time of screening

Design outcomes

Primary

Measure	Time frame
To assess the functional outcomes of the Knee post- ACL Reconstruction Procedure. Timepoint: Screening/ Baseline, month 3, month 6, and month 12	—

Secondary

Measure	Time frame
1.To assess the clinical symptoms and activity level 2.To assess the failure rate of ACL reconstruction 3.To assess the change in quality of life in patients 4.To assess the duration of surgery 5.To assess the overall intraoperative handling. 6.To assess the safety of the implants Timepoint: 1.Screening/ Baseline, month 3, month 6, and month 12 2.All visits after surgery including surgery day. 3.Screening/ Baseline,month 12 4.During surgery 5.During Surgery 6. All visits after surgery including surgery day	—

Measure

Time frame

1.To assess the clinical symptoms and activity level 2.To assess the failure rate of ACL reconstruction 3.To assess the change in quality of life in patients 4.To assess the duration of surgery 5.To assess the overall intraoperative handling. 6.To assess the safety of the implants Timepoint: 1.Screening/ Baseline, month 3, month 6, and month 12 2.All visits after surgery including surgery day. 3.Screening/ Baseline,month 12 4.During surgery 5.During Surgery 6. All visits after surgery including surgery day

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Countries

India

Contacts

Public ContactDr Kalpesh Maheshchandra Trivedi

Aadya Arthroscopy and OrthoSports Hospital

drkalpesh@yahoo.com9825281710

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026