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Acute Anterior Cruciate Ligament Rupture; RecOnsTruction Or Repair? (ROTOR)

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ClinicalTrials.gov Identifier: NCT02310854
Recruitment Status : Active, not recruiting
First Posted : December 8, 2014
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Rianne Huis in 't Veld, Orthopedisch Centrum Oost Nederland

Brief Summary:
To investigate the hypothesis that suture repair of a ruptured vkb, combined with a dynamic intraligamentary stabilization and microfracture of the femoral notch, results in at least equal effectiveness compared with an ACL reconstruction using autologous hamstring in terms of functional recovery one year postoperatively in terms of a patient self-reported outcome related to be able to conduct daily and sporting activities. Secondary, the evaluation of clinical outcomes, self-reported by the patient outcomes, osteoarthritis, rehabilitation time required for return to daily and sporting activities and levels of sporting activity which has returned in patients with status after an ACL rupture and suture repair augmented with a dynamic intraligamentary microfracture and stabilization of the femoral notch in comparison with an anterior cruciate ligament reconstruction with the ipsilateral hamstring graft.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injury Procedure: ACL Repair Procedure: ACL reconstruction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Acute Anterior Cruciate Ligament Rupture; RecOnsTruction Or Repair?
Actual Study Start Date : November 2014
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : November 2029

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ACL Reconstruction
Primary reconstructive surgery of ACL with hamstring autograft (All-inside, Arthrex, Napels, Florida, USA)
Procedure: ACL reconstruction
reconstruction hamstring autograft
Other Names:
  • Primary ACL reconstruction
  • Autograft hamstring
  • All-inside

Experimental: ACL Repair
Primary augmented suture of ACL using Dynamic Intraligament Stabilization (DIS; Mathys Medical Bettlach, Switzerland)
Procedure: ACL Repair
augmented suture of acute ACL rupture (<3 weeks after injury)
Other Names:
  • Dynamic Intraligament Stabilization (DIS)
  • Augmented suture




Primary Outcome Measures :
  1. IKDC 2000 subjective knee evaluation form [ Time Frame: baseline, 12 months post surgery ]
    questionniare/self-reported functional limitations in activitities of daily living and/or sports activities


Secondary Outcome Measures :
  1. IKDC 2000 subjective knee evaluation form [ Time Frame: baseline, 6 weeks, 3-6-9-12 months, 2-5-10 years post surgery ]
    questionnaire/self-reported functional limitations in activitities of daily living and/or sports

  2. IKDC 2000 objective knee evaluation form [ Time Frame: baseline, 6 weeks, 3-6-9-12 months, 2-5-10 years post surgery ]
    knee physical examination form / clinimetrics

  3. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: baseline, 6 weeks, 3-6-9-12 months, 2-5-10 years post surgery ]
    questionnaire designed to assess short and long term patient-related ouctome following knee injury on pain, symptoms, activities of daily living, sport and recreation, knee-related quality of life

  4. Tegner Activity Level Scale [ Time Frame: baseline, 6 weeks, 3-6-9-12 months, 2-5-10 years post surgery ]
    Rating scale to determine the type and intensity of sports/activities

  5. Instrumented anteroposterior laxity [ Time Frame: baseline, 6 weeks, 3-6-9-12 months, 2-5-10 years post surgery ]
  6. LSI jump-force testing [ Time Frame: 6-9-12 months, 2-5-10 years post surgery ]
    leg symmetry index for jump tests as well as isokinetic quadriceps and hamstring force tests


Other Outcome Measures:
  1. Reinjuries [ Time Frame: up till 10 years post surgery ]
    reinjuries or reruptures of the knee

  2. workability [ Time Frame: baseline, 6 weeks, 3-6-9-12 months, 2-5-10 years post surgery ]
    questionnaire to assess the patient's workability due to knee injury/knee surgery in order to be able to make an estimation of costs benefits between study arms

  3. Classification of type of rupture of the ACL [ Time Frame: during surgery ]
    The surgeon's opinion regarding the classification of the type of rupture of the ACL peroperative.

  4. Complications associated with knee surgery and/or rehabilitation [ Time Frame: baseline, 6 weeks, 3-6-9-12 months, 2-5-10 years post surgery ]
    The complications that occur as a result of the ACL surgery and/or rehabilitation in time.

  5. x-ray knee [ Time Frame: 5 and 10 years post surgery ]
    x-ray will be taken of the knee in order to be able to determine the degree of arthrosis



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sportive, active patient (Tegner score =/>5)
  • Age above 18 untill 30 years at time of inclusion
  • Primary rupture of the anterior cruciate ligament, evidence by history (acute trauma, clicking sensation, swelling within a few hours, instability) and physical examination (positive Lachman, anterior drawer test and/or Pivot shift)
  • Primary rupture indicated by MRI
  • No associated ligamentuous disorde of the knee, evidenced by history, physical examination, x-ray or MRI)
  • Time span between anterior cruciate ligament rupture and operation no longer than 21 days
  • Willingness to comply to advised rehabilitation protocol supervised by (NFVS registrated) sports physiotherapist

Exclusion Criteria:

  • Infection
  • Known hypersensitive response for materials used (Cobalt, chroom, nickel)
  • Serieus pre-existing malaligment of leg indicated for surgery
  • Tendency for excessive scar tisseu formation, such as arthrofibrosis
  • History of previous surgery on leg indicated for surgery
  • History of removal of tendon on leg indicated for surgery
  • Muscular, neurological or vascular disorders negatively affecting healing or rehabilitation
  • Cartilage injury requiring (some kind of) cartilage repair surgery (such as microfracture or cell therapy)
  • Arthrosis more dan ICRS grade 2 evidenced by x-ray
  • Long(er) term use of relevant medication, such as prednisolon or cytostatica
  • Pregnancy
  • Know 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): NCT02310854


Locations
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Netherlands
Orthopedisch Centrum Oost Nederland /ZGT
Hengelo, Netherlands, 7555
Sponsors and Collaborators
Orthopedisch Centrum Oost Nederland
Investigators
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Principal Investigator: R.A.G Hoogeslag, MD OCON
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rianne Huis in 't Veld, PhD, Orthopedisch Centrum Oost Nederland
ClinicalTrials.gov Identifier: NCT02310854    
Other Study ID Numbers: NL5011604414
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: to be determined yet
Keywords provided by Rianne Huis in 't Veld, Orthopedisch Centrum Oost Nederland:
anterior cruciate ligament rupture
autograft
reconstruction
orthopedic surgery
dynamic intraligament stabilization
Additional relevant MeSH terms:
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Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries