Graft Selection in Anatomic Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament Injuries Clinical Trial

— Grafttype  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03073083
• Other study ID #: NL52749.044.16
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2017
• Est. completion date: December 2029

Study information

• Verified date: June 2020
• Source: Orthopedisch Centrum Oost Nederland
• Contact: R.A.G Hoogeslag, MD
• Phone: 0031887085375
• Email: wetenschap[@]ocon.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 Nowadays, the philosophy of isometrie tunnel placement has been abandoned, and has been replaced by the philosophy of anatomie reconstructions.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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 439
• Est. completion date: December 2029
• Est. primary completion date: December 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

Procedure:
• Hamstring tendon autograft
ACL reconstruction surgery with hamstring tendon
• Pattella tendon autograft
ACL reconstruction surgery with patella tendon
• Quadriceps tendon autograft
ACL reconstruction surgery with quadriceps tendon

Locations

Country	Name	City	State
Netherlands	Martini Hospital Groningen	Groningen
Netherlands	OCON	Hengelo

Sponsors (3)

Lead Sponsor	Collaborator
Orthopedisch Centrum Oost Nederland	Gelderse Vallei Hospital, Martini Hospital Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	questionnaire	level of physical activity (Lysholm score)	preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery
Secondary	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
Secondary	Instability knee	VAS score (patient perception)	preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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