ClinicalTrials.gov
ClinicalTrials.gov Menu

Graft Selection in Anatomic Anterior Cruciate Ligament Reconstruction (Grafttype)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03073083
Recruitment Status : Recruiting
First Posted : March 8, 2017
Last Update Posted : December 22, 2017
Sponsor:
Collaborator:
Martini Hospital Groningen
Information provided by (Responsible Party):
Orthopedisch Centrum Oost Nederland

Brief 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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injuries Procedure: Hamstring tendon autograft Procedure: Pattella tendon autograft Procedure: Quadriceps tendon autograft Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 519 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Graft Selection in Anatomic Anterior Cruciate Ligament Reconstruction: Patella, Hamstrings or Quadriceps Tendon Autograft
Actual Study Start Date : March 6, 2017
Estimated Primary Completion Date : September 2029
Estimated Study Completion Date : December 2029

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: all-inside AMPS technique Arthrex




Primary Outcome Measures :
  1. Physical examination ACL Failure [ Time Frame: 2 years after ACL reconstruction surgery ]
    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.


Secondary Outcome Measures :
  1. quality of life (ACL-QoL) [ Time Frame: preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery ]
    level of self-reported quality of life

  2. functional knee and health status (IKDC) [ Time Frame: preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery ]
    level of functional knee and current health status

  3. physical examination of knee (in)stability [ Time Frame: preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery ]
    instability in the absence of any pathological laxity and/or discontinuïty of the graft on MRl or arthroscopy.

  4. Knee and Injury Osetoarthritis Outcome Score questionnaire (KOOS) [ Time Frame: preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery ]
    self-reported level of physical activity in daily life

  5. sports intensity questionnaire (Tegner Activity Level) [ Time Frame: preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery ]
    self-reported level of pivoting sports execution

  6. questionnaire [ Time Frame: preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery ]
    level of physical activity (Lysholm score)

  7. knee pain [ Time Frame: preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery ]
    self-reported level of pain during activity and rest on visual analogue scale

  8. Instability knee [ Time Frame: preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery ]
    VAS score (patient perception)

  9. satisfaction with result of ACL surgery [ Time Frame: 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery ]
    self-reported level of satisfaction with ACL surgery on visual analogue scale

  10. physical examination [ Time Frame: 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery ]
    degree of knee (in)stability during jumping tests (Leg Symmetry Index)

  11. physical examination [ Time Frame: preoperative, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery ]
    degree of knee (in)stability in strenght (Leg Symmetry Index)

  12. Lachman test [ Time Frame: 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery ]
    physical examination: degree of knee (in)stability measured by rollimeter (operated-nonoperated side ratio)

  13. Degree of Osteoarthritis on x-ray [ Time Frame: Baseline, 1,2,5 10 years after ACL reconstruction surgery ]
    Kellgren-Lawrence classification will be applied to assess the degree of osteoarthritis


Other Outcome Measures:
  1. Knee instability during jumping movements [ Time Frame: 1 and 2 years after ACL reconstruction surgery ]
    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

  2. Complications and other adverse events [ Time Frame: 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery ]
    number and type complications and adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03073083


Contacts
Contact: R.A.G Hoogeslag, MD 0031887085375 wetenschap@ocon.nl

Locations
Netherlands
Martini Hospital Groningen Not yet recruiting
Groningen, Netherlands, 9728 NT
Contact: R Brouwer, MD    03188524 5970      
Sub-Investigator: R. Brouwer         
Sub-Investigator: A de Vries         
OCON Recruiting
Hengelo, Netherlands
Contact: R. Huis in 't Veld, Phd    0031887085375    wetenschap@ocon.nl   
Principal Investigator: R.A.G Hoogeslag, MD         
Sub-Investigator: R Huis in 't Veld         
Sponsors and Collaborators
Orthopedisch Centrum Oost Nederland
Martini Hospital Groningen
Investigators
Principal Investigator: R.A.G Hoogeslag, MD OCON

Responsible Party: Orthopedisch Centrum Oost Nederland
ClinicalTrials.gov Identifier: NCT03073083     History of Changes
Other Study ID Numbers: NL52749.044.16
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Orthopedisch Centrum Oost Nederland:
autograft

Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries