Graft Selection in Anatomic Anterior Cruciate Ligament Reconstruction (Grafttype)

Graft Selection in Anatomic Anterior Cruciate Ligament Reconstruction: Patella, Hamstrings or Quadriceps Tendon Autograft

A rupture of the anterior cruciate ligament (ACL) is a severe injury of the knee. The current gold Standard treatment for young and active patients with instability, is a surgical ACL reconstruction. However, there still is no consensus on which graft is best suited for this.The aim of the current multi-center randomized controlled trial was to investigate the hypothesis that an anatomic single bundle anterior cruciate ligament reconstruction with a (flat) quadriceps tendon autograft is at least as effective as reconstruction of the ruptured anterior cruciate ligament with a patella tendon autograft or a hamstringtendon autograft, in terms of failure, measured 2 years postoperatively. Failure is defined gedefinieerd as pathologicai laxity, complaints of knee instability in the absence of any pathological laxity and/or discontinuïty ofthe graft on MRl or arthroscopy.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Procedure: Hamstring tendon autograft; Procedure: Pattella tendon autograft; Procedure: Quadriceps tendon autograft

Detailed Description

A rupture of the anterior cruciate ligament (ACL) is a severe injury of the knee. The current gold Standard treatment for young and active patients with instability, is a surgical ACL reconstruction. However, there still is no consensus on which graft is best suited for this.

Paradigms on the different types of auto grafts and their weaknesses and benefits originate mostly from the eighties and nineties, when the patella tendon was being replaced by the hamstring graft as the 'new' gold standerd. Nowadays, the philosophy of isometrie tunnel placement has been abandoned, and has been replaced by the philosophy of anatomie reconstructions. The question then arises: Are the results of the comparative studies, and the current paradigms, still applicable, now that the philosophy has transitioned from isometric to anatomic tunnel placement? Irrespective of the disadvantages compared to the patellatendon autograft, such as a higher re-rupture and revision percentage when used in patients under 25 years old, the hamstring autograft is currently the most used graft for ACL reconstruction worldwide. The question then arises: is it justified that the hamstringgraft is the most used graft worldwide? Rehabilitation protocols are often not, or poorly, described, despite it's significant effect on the outcome and co morbidity of an ACL reconstruction. Especially anterior knee pain, which is often mentioned as a disadvantage of the patellagraft, is significantly influenced by rehabilitation protocols. The introduction and implementation of a nation-wide evidence-based rehabilitation protocol in The Netherlands created uniformity of rehabilitation treatment, and the possibility to generalize scientific conclusions. The question then arises: Due to new insights in rehabilitation and implementation of new protocols, is the anterior knee pain, the often mentioned disadvantage ofthe patelia tendon graft, stiil a relevant disadvantage? The quadriceps tendon autograft is a less often used graft. Nevertheless, research has shown that it seems like a good alternative for the patella tendon and hamstring autograft. Functional outcome is similar, while less donorsite morbidity is reported compared to the patellatendon and hamstring autograft. The question then arises: Is it fair that the quadriceps tendon is rarely used as an autograft for ACL reconstruction? Increasing knowledge of the anatomy of the ACL results in new insights in the methods to achieve true anatomie ACL reconstruction. New arguments support the use of the patella tendon - and even the quadriceps tendon - over the use of the hamstringgraft, because their anatomic similarities to the anterior cruciate ligament might be better suited to restore knee kinematics. The question then arises: are the flat-shaped patella tendon autograft and quadriceps tendon autograft better suited to restore the anatomy of the ruptured ACL than the round hamstring graft? Hypothesis Tlie hypothesis is that anatomic reconstruction ofthe ruptured anterior cruciate ligament with a (flat) quadriceps tendon autograft is at least as effective as reconstruction of the ruptured anterior cruciate ligament with a patella tendon autograft or a hamstring tendon autograft, in terms of failure, measured 2 years postoperatively. Failure is defined as pathological laxity, complaints of knee instability in the absence of any pathological laxity and/or discontinuïty of the graft on MRl or arthroscopy.

Objective of the study:

Primary objective:

To investigate the hypothesis that an anatomic single bundle anterior cruciate ligament reconstruction with a (flat) quadriceps tendon autograft is at least as effective as reconstruction of the ruptured anterior cruciate ligament with a patella tendon autograft or a hamstring tendon autograft, in terms of failure, measured 2 years postoperatively. Failure is defined gedefinieerd as pathologicai laxity, complaints of knee instability in the absence of any pathological laxity and/or discontinuïty of the graft on MRl or arthroscopy.

Secondary objectives:

patiënt reported outcome measures (PROMs), clinimetrics, radiological assessment, duration of rehabilitation necessary for return to sports and daily activities and the level of sport activities to which the patiënt returned, in patients treated with an anterior cruciate ligament reconstruction using a patellatendon autograft, hamstringtendon autograft of quadricepstendon autograft, as measured in the short-term (6 weeks, 6,9,12 months postoperatively), mid-term (2 years postoperatively) and long-term (5 and 10 years postoperatively).

Study design:

Multicenter blocked stratified randomised controlled trial with varying block sizes (n=3, 6, 9, 12). Patients with an anterior cruciate ligament rupture, confirmed by an orthopaedie surgeon (as evident from anamnesis, physical examination and radiographic imaging) who meet the inclusion criteria and do not have any of the exclusion criteria, will be asked to partieipate in this study.

Baseline measurements will be performed, after informed consent is obtained. Allocation of treatment of the included patients will be performed in the operating room (OR), where patients will be randomised (blocked and stratified) per clinic, to have ACL reconstruction with a patella tendon autograft, hamstring tendon autograft or quadriceps tendon autograft. Stratification will be based on age (18-25 and >25), level of sport activities (Tegner Activity Level Scale 5-7 and 8-10) and surgeon.

Follow-up identical to the follow-up of standard care, with standard checkups after 6 weeks, 6, 9, months and 1 and 2 years. Two extra follow-up moments (after 5 and 10 years) will be planned.

• Study Type: Interventional
• Enrollment (Anticipated): 439
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: R.A.G Hoogeslag, MD; Phone Number: 0031887085375; Email: wetenschap@ocon.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NT
    • Not yet recruiting
    • Martini Hospital Groningen
    • Contact: R Brouwer, MD; Phone Number: 03188524 5970
    • Sub-Investigator: R. Brouwer
    • Sub-Investigator: A de Vries
  • Hengelo, Netherlands
    • Recruiting
    • OCON
    • Contact: R. Huis in 't Veld, Phd; Phone Number: 0031887085375; Email: wetenschap@ocon.nl
    • Principal Investigator: R.A.G Hoogeslag, MD
    • Sub-Investigator: R Huis in 't Veld

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients active in sports, Tegner =/>5
• Primary ACL rupture, evident from anamnesis (acute trauma, snapping sensation, swelling within several hours, feeling of instability), physical examination (positive Lachman test, anterior drawertest and/or pivot shift test), radiograph and MRl
• Willing to comply to the suggested (nationwide standard) rehabilitation protocol, supen/ised by a NFVS registerd sport-physical therapist
• <6 months between initial trauma and surgery

Exclusion Criteria:

• History of knee surgery on the same side
• History of tendon removal on the same side
• Accompanying ligament injury ofthe knee, evident from anamnesis, physical examination, radiograph and MRl, defined as an ACL rupture in combination with a posterior cruciate ligament or collateral ligament injury,
• Peroperative discovery of cartilage damage; larger than 2cm2 and more than 50% depth
• Peroperative discovery of meniscus injury witch requires a meniscectomy of more than 20% or meniscus sutures
• Osteoarthritis of Kellgren and Lawrence grade 2 or more, as evident from the radiograph
• Severe malalignment of the leg
• Tendency to form excessive scar tissue, such as arthrofibrosis
• Muscular, neurological or vascular anomalies that influence healingtime or rehabilitation
• Infection
• Known hypersensitivity to any of the used materials
• Long term relevant medication use such as prednisolone or cytostatics
• Pregnancy at the time of inclusion or surgery
• Known osteoporosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hamstring tendon autograft; ACL reconstruction surgery with hamstring tendon autograft	Procedure: Hamstring tendon autograft; ACL reconstruction surgery with hamstring tendon; Other Names: all-inside AMPS technique Arthrex
Active Comparator: Patella tendon autograft; ACL reconstruction surgery with pattella tendon autograft	Procedure: Pattella tendon autograft; ACL reconstruction surgery with patella tendon; Other Names: Smith and Nephew
Active Comparator: Quadriceps tendon autograft; ACL reconstruction surgery with quadriceps tendon autograft	Procedure: Quadriceps tendon autograft; ACL reconstruction surgery with quadriceps tendon; Other Names: all-inside AMPS technique Arthrex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical examination ACL Failure	Presence / absence of anterior cruciate ligament failure. Failure is defined as pathologicai laxity, complaints of knee instability in the absence of any pathological laxity and/or discontinuïty ofthe graft on MRl or arthroscopy.	2 years after ACL reconstruction surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life (ACL-QoL)	level of self-reported quality of life	preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery
functional knee and health status (IKDC)	level of functional knee and current health status	preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery
physical examination of knee (in)stability	instability in the absence of any pathological laxity and/or discontinuïty of the graft on MRl or arthroscopy.	preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery
Knee and Injury Osetoarthritis Outcome Score questionnaire (KOOS)	self-reported level of physical activity in daily life	preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery
sports intensity questionnaire (Tegner Activity Level)	self-reported level of pivoting sports execution	preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery
questionnaire	level of physical activity (Lysholm score)	preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery
knee pain	self-reported level of pain during activity and rest on visual analogue scale	preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery
Instability knee	VAS score (patient perception)	preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery
satisfaction with result of ACL surgery	self-reported level of satisfaction with ACL surgery on visual analogue scale	6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery
physical examination	degree of knee (in)stability during jumping tests (Leg Symmetry Index)	6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery
physical examination	degree of knee (in)stability in strenght (Leg Symmetry Index)	preoperative, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery
Lachman test	physical examination: degree of knee (in)stability measured by rollimeter (operated-nonoperated side ratio)	6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery
Degree of Osteoarthritis on x-ray	Kellgren-Lawrence classification will be applied to assess the degree of osteoarthritis	Baseline, 1,2,5 10 years after ACL reconstruction surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee instability during jumping movements	Measured during jumping test. At OCON patients will be equiped with 3D accelerometer sensors in order to quantify the degree of (in)stability of the affected knee during the execution of jump tests under the supervision of a specialized sports physiotherapist	1 and 2 years after ACL reconstruction surgery
Complications and other adverse events	number and type complications and adverse events	6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery

Collaborators and Investigators

• Sponsor: Orthopedisch Centrum Oost Nederland
• Collaborators: Martini Hospital Groningen; Gelderse Vallei Hospital
• Investigators: Principal Investigator: R.A.G Hoogeslag, MD, OCON

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2017
• Primary Completion (Anticipated): December 1, 2029
• Study Completion (Anticipated): December 1, 2029

Study Registration Dates

• First Submitted: February 23, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 22, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: autograft
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: NL52749.044.16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No