The Effect of Knee Flexion Angle for Graft Fixation During Single-Bundle Anterior Cruciate Ligament Reconstruction

NCT03875807 | Completed DMC

• 1 other identifier: 2014-0006-B
• Study Type: interventional
• Target: 204
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall aim of this study is to determine the effect of the knee flexion angle (KFA) of either 0 degrees, or 30 degrees (measured by sterile goniometer) during anterior cruciate ligament (ACL) fixation on postoperative outcomes following single-bundle ACL reconstruction with bone patellar tendon bone (BPTB) autograft. The specific aims of the current study include determining the effect of the knee flexion angle on 1) patient-reported outcomes; 2) postoperative extension loss; 3) antero-posterior (AP) knee stability; 4) rate of re-operation.

Conditions

Anterior Cruciate Ligament Injury

Keywords

ACL; ACL reconstruction; Knee Flexion Angle; Bone Patellar Tendon Bone

Outcome Measures

Primary Outcomes (1)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  The KOOS questionnaire consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  Completed 24 months post ACL repair at 0 or 30 degrees flexion

Secondary Outcomes (5)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Completed 3, 6 and 12 months post ACL repair at 0 or 30 degrees flexion

• Marx Activity Score questionnaire

  Completed at 3, 6, 12, 24 months post ACL repair at 0 or 30 degrees flexion

• Loss of Extension on Operative Knee

  Extension is measured at 3, 6, 12 and 24 months post ACL repair

• Side to side differences in Anterior Posterior joint stability as measured by the KT-1000 Arthrometer

  KT-1000 measurements are recorded at 3, 6,12 and 24 months post ACL repair

• Rate of Reoperation

  Patients are followed for 24 months post initial ACL surgery to capture any instances of reoperation on the affected knee

Study Arms (2)

0 degree Knee Flexion Angle ACLR

ACTIVE COMPARATOR

At the time of surgery, tunnel position and surgical technique will be standardized for transtibial and anteromedial portal ACLR. Individuals randomized to this arm intra-operatively to undergo fixation of the ACL graft on the tibial side at a KFA of 0 degrees as measured by a sterile goniometer. Grafts will be tensioned according to the maximum surgeon-applied tension at the designated KFA. After surgery, patients will be treated with a standardized accelerated physical therapy protocol

Procedure: ACLR done at 0 degrees KFA

30 degree Knee Flexion Angle ACLR

ACTIVE COMPARATOR

At the time of surgery, tunnel position and surgical technique will be standardized for transtibial and anteromedial portal ACLR. Individuals randomized to this arm intra-operatively to undergo fixation of the ACL graft on the tibial side at a KFA of 30 degrees as measured by a sterile goniometer. Grafts will be tensioned according to the maximum surgeon-applied tension at the designated KFA. After surgery, patients will be treated with a standardized accelerated physical therapy protocol

Procedure: ACLR done at 30 degrees KFA

Interventions

ACLR done at 0 degrees KFA PROCEDURE

Patients randomized to this arm will undergo the following intervention: Anterior Cruciate Ligament Reconstruction (ACLR) done at 0 degrees knee angle flexion (KFA)

0 degree Knee Flexion Angle ACLR

ACLR done at 30 degrees KFA PROCEDURE

Patients randomized to this arm will undergo the following intervention: Anterior Cruciate Ligament Reconstruction (ACLR) done at 30 degrees knee angle flexion (KFA)

30 degree Knee Flexion Angle ACLR

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients older than 16 years old with an isolated anterior cruciate ligament injury as diagnosed by clinical examination and MRI
• No pre-existing arthritis as defined by the Kellgren-Lawrence radiographic rating system
• Patients treated with an initial period of rehabilitation to eliminate swelling, optimize quadriceps strength and restore range of motion
• Surgical management with a transtibial or anteromedial portal single-bundle ACLR with bone patella tendon bone (BPTB) autograft by a fellowship-trained sports medicine surgeon.
• Provision of Informed Consent

You may not qualify if:

• Acute ACL injuries that have not undergone an initial period of physical therapy in order to restore the aforementioned parameters
• Associated grade III injury to the MCL (medial opening \>10mm at 30 degrees of knee flexion or any medial opening in extension);
• Presence of a PCL or posterolateral corner injury
• Lack of informed consent.

Sponsors & Collaborators

• Women's College Hospital: lead
• Arthroscopy Association of North America: collaborator

Related Publications (1)

• Chahal J, Whelan DB, Hoit G, Theodoropoulos J, Ajrawat P, Betsch M, Docter S, Dwyer T. Anterior Cruciate Ligament Patellar Tendon Autograft Fixation at 0 degrees Versus 30 degrees Results in Improved Activity Scores and a Greater Proportion of Patients Achieving the Minimal Clinical Important Difference For Knee Injury and Osteoarthritis Outcome Score Pain: A Randomized Controlled Trial. Arthroscopy. 2022 Jun;38(6):1969-1977. doi: 10.1016/j.arthro.2021.12.018. Epub 2021 Dec 22.

  PMID: 34952186 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Jas Chahal, MD, MSc, MBA

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients, assessors, and data analysts will be blinded in regards to treatment status at all times. Surgeons cannot be blinded given the nature of the intervention. We do not anticipate any circumstance in which unmasking of the data management team, or data analysts will be required, or permissible
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon, Principle Investigator

Model Details: A Multicentre, Pragmatic, Patient and Assessor Blinded, Stratified, Two-arm Parallel (1:1) Group Superiority Trial

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 15, 2019
• Study Start: April 16, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 19, 2020

Record last verified: 2020-05