Fixed Versus Adjustable Loop in ACL Reconstruction

NCT03184922 | Active Not Recruiting DMC

• 1 other identifier: 1711539
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

Study Aims and Objectives: To investigate the following null hypothesis: that there is no difference in clinical and functional outcome when comparing outcomes of Anterior Cruciate Ligament (ACL) reconstruction when comparing femoral side graft fixation with either a fixed versus an adjustable suspensory loop system. The research team will achieve this aim by:

• Enrolling 150 patients into this study over a period of 2 years and 8 months
• Carrying out a prospective randomised study looking at the subject matter over a period of 5 years and 8 months
• Analysing patients functional status pre and post-surgery using patient generated questionnaires
• Quantitatively measuring knee joint laxity using the KT1000 testing device at the 3, 6 and 12 month post-surgery time frames
• Collating the data received into a spread sheet for analysis by a professional statistician. It is not uncommon to tear the anterior cruciate ligament (ACL) particularly during sporting activities. Younger and sportier patients will often have this ligament reconstructed so as to allow them to return to sport with a stable knee joint that they feel they can trust. Various surgical techniques exist to perform ACL reconstruction. In Exeter, the favoured technique is to reconstruct the ligament by taking two of the hamstring tendons from the back of the knee and creating a graft with these, passing them through a bony tunnel to replace the torn ACL. On the shin bone side of the knee the graft is fixed in place using a screw. On the thigh bone side, the graft is attached to a device known as a suspensory loop. The length of the graft and the length of the tunnel in the thigh bone vary from patient to patient. It is important to get a good length of the graft material in both the shin and thigh bones so as to give the best chance of the graft attaching to the surrounding bone. With the fixed loop system, once the metal button attached to the outer thigh bone is in place, the length of the loop cannot be adjusted. Thus the amount of hamstring graft in either end of the bony tunnel cannot be changed. One potential advantage of an adjustable loop system is that the amount of graft in either end of the bone tunnel can be altered to ensure sufficient graft is accurately placed. The research team are planning to run this study to identify which type of loop system gives the best outcome for patients, examining the results in different ways including questionnaires to measure how well the patients feel their knee is performing, and specific tests to measure knee function. If patients consent to be in the study, they will be randomly allocated to receive one of the 2 ACL reconstruction options above and their progress monitored for 2 years after the operation. All aspects of surgical care will be as routine practice apart from the decision to fix the graft to the thigh bone with an adjustable or fixed suspensory loop.

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

femoral suspensory loops

Outcome Measures

Primary Outcomes (1)

• The assessment of knee joint stability via a comparison of left and right sided anterior tibial translation

  Anterior tibial translation will be assessed using the KT1000 device using a students t-test or a non-parametric equivalent if the data is not normally distributed e.g. the Mann- Whitney u test to compare the groups. The Minimal Clinically Important Difference between the groups will be 0.6mm above the acceptable threshold of 3mm

  12 months after surgery

Secondary Outcomes (12)

• An assessment of Functional outcome (1) using the results of the Knee Osteo-Arthritis Outcome Score (KOOS)

  6 months after surgery

• An assessment of Functional outcome (2) using the results of the Knee Osteo-Arthritis Outcome Score (KOOS)

  12 months after surgery

• An assessment of Functional outcome (3) using the results of the Knee Osteo-Arthritis Outcome Score (KOOS)

  24 months after surgery

• An assessment of Functional outcome (4) using the results of the International Knee Documentation Committee (IKDC) subjective questionnaire

  6 months after surgery

• IKDC subjective knee questionnaire

  12 months after surgery

Study Arms (2)

Fixed suspensory loop

ACTIVE COMPARATOR

Non-adjustable femoral cortical fixation device to be used

Procedure: Adjustable versus fixed suspensory loop femoral side graft fixation

Adjustable suspensory loop

EXPERIMENTAL

Adjustable femoral cortical fixation device to be used

Procedure: Adjustable versus fixed suspensory loop femoral side graft fixation

Interventions

Adjustable versus fixed suspensory loop femoral side graft fixation PROCEDURE

A comparison of 2 different types of surgical technique for attaching the femoral side graft in ACL reconstruction: with a fixed suspensory loop or an adjustable one

Adjustable suspensory loop; Fixed suspensory loop

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Isolated ACL deficient knee without other ligament injury

You may not qualify if:

• Patient has signed an ethics committee approved consent form
• Surgery to be performed at either at The Royal Devon and Exeter Hospital or Sidmouth Hospital.
• Patient is willing and able to comply with postoperative scheduled clinical and functional evaluations and rehabilitation
• Patients undergoing ACL reconstruction using hamstring autograft
• Patients \<16 years old
• Refusal to consent to participate in the study
• Previous knee surgery or serious knee injuries in the operative knee
• Obvious clinical knee malalignment-i.e. visible on clinical examination
• Multi ligament knee injuries.
• Moderate to severe degenerative changes present within the knee joint.
• If a simultaneous sub-total meniscectomy involving 50% or more of the meniscus has to be performed
• Patients who also have a postero-lateral corner injury
• Patient has a neuromuscular or neurosensory deficiency
• Pregnancy

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead
• Stryker Nordic: collaborator

Study Sites (1)

Royal Devon and Exeter Hospital

Exeter, Devon, EX2 5DW, United Kingdom

Location

Study Officials

• Andrew Toms, MSc FRCS

  RD+E Hospital NHSFT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 1. The patients will be informed they will not be told which arm of the study they are allocated to. 2. The outcomes assessor for the KT1000 will be a physiotherapist not a surgeon and will not be told which type of surgery the patient has undergone
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a blinded randomised controlled trial with 1 arm of the study having femoral side cortical fixation using a fixed length suspensory loop and the other an adjustable loop

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: June 14, 2017
• Study Start: July 5, 2017
• Primary Completion: November 1, 2023
• Study Completion: January 31, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)