Other Clinical Trial - Comparison of Three Methods for Anterior Cruciate

Status Active, not recruiting

Clinical Trial Summary

The purpose of this randomized clinical trial is to determine the difference in quality of life outcome at two years, in patients undergoing an Anterior Cruciate Ligament (ACL) reconstruction procedure with either a patellar tendon, quadruple hamstring tendon or a double-bundle hamstring tendon autograft.

Clinical Trial Description

Following an ACL injury, the knee is predisposed to chronic instability, further damage to the meniscal and chondral structures in the knee, osteoarthritis and an impaired quality of life. The successful treatment of an ACL deficient knee aims to preserve the intact meniscus and chondral structures, and to provide a functionally stable knee so that patients can return to pre-injury activities and restore their quality of life. The current standard of care for ACL deficient knees is with a surgical ACL reconstruction procedure. A Cochrane Review was done and demonstrated that the existing literature is controversial. To date, no existing trial has used validated patient-based outcome assessment, accounted for the critical differences between acute and chronic ACL deficiency or used modern techniques to ensure randomization concealment and a sufficient sample size to avoid type II error. The existing information does not define graft failure or re-ruptures, involve long-term follow-up to address osteoarthritis development, nor compare outcomes between single- and double-bundle reconstructive techniques. The current standard includes either a patellar tendon or quadruple semitendinosus/gracilis tendon autograft reconstruction. The newest option is a double-bundle semitendinosus/gracilis graft. This option attempts to restore the complex ACL anatomy by using two separate tendon components to reconstruct the ACL. This study will measure disease-specific quality of life at short- and long-term post-operative intervals (1, 2, 5 and 10 years). Additional secondary outcomes, including the incidence of traumatic re-ruptures and graft failures, will also be compared between treatment groups. ;

Study Design

Related Conditions & MeSH terms

Anterior Cruciate Ligament Injuries
Anterior Cruciate Ligament Injury
Anterior Cruciate Ligament Rupture
Chronic Instability of Knee
Deficiency of Anterior Cruciate Ligament
Rupture

Clinical Trial Details

NCT number	NCT00529958
Study type	Interventional
Source	University of Calgary
Contact
Status	Active, not recruiting
Phase	N/A
Start date	September 2007
Completion date	December 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05487768` - Functional Connectivity After Anterior Cruciate Ligament Reconstruction	N/A
Recruiting	`NCT04390035` - BFRT in Adolescents After ACL Reconstruction	N/A
Recruiting	`NCT02740452` - Anterior Cruciate Ligament Rupture	N/A
Not yet recruiting	`NCT02555917` - Comparison of Remnant Preserving Versus Remnant Resecting Anterior Cruciate Ligament Reconstruction	N/A
Completed	`NCT05109871` - Reliability and Validity of Inline Dynamometry Study for Measuring Knee Extensor Torque	N/A
Not yet recruiting	`NCT06048874` - FNB in ACL Recon Under SA	N/A
Not yet recruiting	`NCT06048848` - FNB in ACL Recon Under GA	N/A
Terminated	`NCT03529552` - Evaluation After Reconstruction of the Anterior Cruciate Ligament of the Knee Using the Bioresorbable Interference Screw (SMS): Resorbability, Per- and Post-operative Complications and Articular Functional Recovery.	N/A
Completed	`NCT04285853` - Are Opioids Needed After ACL Reconstruction	Phase 4
Recruiting	`NCT04088227` - Effects of Platelet Rich Plasma Injections on Biomarkers After Anterior Cruciate Ligament Tears	Phase 2
Active, not recruiting	`NCT03671421` - Number One Overall Graft Pick? Hamstring vs Bone-Patellar-Tendon-Bone vs Quadriceps Tendon	N/A
Not yet recruiting	`NCT04957706` - Diagnostic Study of ACL Rupture With Anterior Drawer Test at 90° of Hip Flexion
Not yet recruiting	`NCT04953676` - A Clinical Trial of the Round-tunnel and Flat-tunnel Technique of ACL Reconstruction	N/A
Enrolling by invitation	`NCT03365908` - Pain Management of ACL Reconstruction	N/A
Recruiting	`NCT06030791` - BTB Graft Harvest and Donor Site Morbidity After ACL Reconstruction
Recruiting	`NCT03950024` - Improvement of Knowledge About the Arthrogenic Muscle Inhibition in the Aftermath of Knee Trauma.	N/A
Recruiting	`NCT03229369` - Association of ALL and ACL Reconstruction Versus Isolated ACL Reconstruction in High-risk Population: a RCT.	N/A
Completed	`NCT01267435` - Evaluation of Tibial and Femoral Tunnel Position After Arthroscopic Reconstruction of the Anterior Cruciate Ligament	Phase 2
Recruiting	`NCT06430775` - Exploring Prolonged AMR in ACL Reconstructed Patients
Completed	`NCT05057442` - The Effects of Remnant-Preserving Anterior Cruciate Ligament Reconstruction on Proprioception and Functionality

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms