NCT03073083

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
439

participants targeted

Target at P75+ for not_applicable

Timeline
67mo left

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Mar 2017Dec 2031

First Submitted

Initial submission to the registry

February 23, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

March 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
14.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2031

Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

14.7 years

First QC Date

February 23, 2017

Last Update Submit

November 20, 2025

Conditions

Anterior Cruciate Ligament Injuries

Keywords

autograft

Outcome Measures

Primary Outcomes (1)

  • 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. Graft failure at 2 years (originally registered). Due to premature termination, this outcome was underpowered and analyzed exploratorily. The IKDC Subjective Knee Form score was analyzed as the main outcome in the final report. The IKDC subjective score was already powered at study design (-10 points non-inferiority margin; n = 23 per group, 80% power).

    2 years after ACL reconstruction surgery

Secondary Outcomes (13)

  • quality of life (ACL-QoL)

    preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery

  • functional knee and health status (IKDC)

    preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery

  • physical examination of knee (in)stability

    preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery

  • Knee and Injury Osetoarthritis Outcome Score questionnaire (KOOS)

    preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery

  • sports intensity questionnaire (Tegner Activity Level)

    preoperative, 6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery

  • +8 more secondary outcomes

Other Outcomes (2)

  • Knee instability during jumping movements

    1 and 2 years after ACL reconstruction surgery

  • Complications and other adverse events

    6 wks, 6 months, 9 months, 1, 2, 5 10 years after ACL reconstruction surgery

Study Arms (3)

Hamstring tendon autograft

ACTIVE COMPARATOR

ACL reconstruction surgery with hamstring tendon autograft

Procedure: Hamstring tendon autograft

Patella tendon autograft

ACTIVE COMPARATOR

ACL reconstruction surgery with pattella tendon autograft

Procedure: Pattella tendon autograft

Quadriceps tendon autograft

ACTIVE COMPARATOR

ACL reconstruction surgery with quadriceps tendon autograft

Procedure: Quadriceps tendon autograft

Interventions

Hamstring tendon autograftPROCEDURE

ACL reconstruction surgery with hamstring tendon

Also known as: all-inside AMPS technique Arthrex
Hamstring tendon autograft
Pattella tendon autograftPROCEDURE

ACL reconstruction surgery with patella tendon

Also known as: Smith and Nephew
Patella tendon autograft
Quadriceps tendon autograftPROCEDURE

ACL reconstruction surgery with quadriceps tendon

Also known as: all-inside AMPS technique Arthrex
Quadriceps tendon autograft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Known osteoporosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Martini Hospital Groningen

Groningen, 9728 NT, Netherlands

Location

OCON

Hengelo, Netherlands

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • R.A.G Hoogeslag, MD

    OCON

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2017

First Posted

March 8, 2017

Study Start

March 6, 2017

Primary Completion (Estimated)

December 1, 2031

Study Completion (Estimated)

December 1, 2031

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)