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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

Tracking Information
First Submitted Date  ICMJE December 1, 2014
First Posted Date  ICMJE December 8, 2014
Last Update Posted Date June 23, 2020
Actual Study Start Date  ICMJE November 2014
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2014)
  • 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
  • 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
  • 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
  • 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
  • Instrumented anteroposterior laxity [ Time Frame: baseline, 6 weeks, 3-6-9-12 months, 2-5-10 years post surgery ]
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 4, 2014)
  • Reinjuries [ Time Frame: up till 10 years post surgery ]
    reinjuries or reruptures of the knee
  • 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
  • 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.
  • 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.
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Acute Anterior Cruciate Ligament Rupture; RecOnsTruction Or Repair?
Official Title  ICMJE Acute Anterior Cruciate Ligament Rupture; RecOnsTruction Or Repair?
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.
Detailed Description

Background of the study:

An anterior cruciate ligament rupture is a serious injury to the knee with high probability of the occurrence of dynamic instability, accompanying lesions and early post-traumatic arthrosis. Despite conservative treatment through rehabilitation or ACL reconstruction surgery not all patients do return to their previous activity levels. Moreover degenerative changes, especially early posttraumatic arthrosis, are not counteracted.

In order to optimize the clinical results after ACL surgery, a renewed interest has emerged in healing the patient's own ruptured ACL after attaching. Literature suggests that with the current innovations in surgical repair techniques of (natural) healing of a ruptured ACL may result in similar clinical outcomes in comparison to the gold standard, the ACL reconstruction. In addition, it may even reduce degenerative changes occur in relation to the gold standard. Moreover, the return to daily activities and sports level seems significantly faster than after ACL reconstruction.

The hypothesis is that a suture (suture repair) of a ruptured ACL, combined with a dynamic intraligamentary stabilization, as well as microfracture of the femoral notch, passes, at least equal efficacy in comparison with an anterior cruciate ligament reconstruction using autologous hamstrings in terms of functional recovery 1 years postoperatively.

The DIS bonding technique will be applied in the current study to surgically repair (suture) the ruptured ACL. DIS is an abbreviation and stands for intraligamentary dynamic stabilization (DIS). DIS has been used in humans and seems to provide a high patient satisfaction, favorable clinical and radiological results. However, to our knowledge, to date, no randomized comparative study has been conducted yet in which the DIS technique is compared with the gold standard, the ACL reconstruction.

Objective of the study:

Primary goal:

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 objective:

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.

Study design:

This study is a single center stratified block randomized controlled trial. Patients with ACL rupture, confirmed by an orthopedic surgeon based on the outpatient history and radiographic images, will be randomized into an experimental ('repair' / DIS) group after inclusion and a control (reconstruction, regular care) group. Patients will be stratified on the level of sport/physical active practice, on the basis of the Tegner score. The Tegner score is an evaluative and inventory questionnaire on which the patient indicates the gravity of his work and/or sports activities. A higher score is associated with a higher level of physical strain/activity . On the basis of the Tegner score patients will be stratified into a 'moderate' physically active stratum (group Tegner score 5-6-7) and 'highly' physically active stratum (group Tegner score 8 -9-10). Stratification based on the degree of physical activity is considered to be important because the extent and severity of physical activity/strain in daily life poses a potential (difference) in risk of re-rupture between the two study arms. In order to minimize potential differences in 'exposure' or 'risk of re-rupture' between the two study groups stratification is relevant.Measurements take place at baseline, peri-operative / immediately after surgery, 6 weeks, 3,6,9 months and 1, 2, 5 and 10 years postoperatively.

Study population: (Physically) active patients from 18 untill 30 years, who has visited the outpatient clinic of the orthopedic surgeon because of a knee injury resulting in a ACL rupture, for whom surgery indication for an ACL reconstruction exists and who can be operated on within three weeks after the onset of the ACL rupture.

Intervention:

n=48 patients will participate in the current study. Patients will be assigned to a suture repair of the ruptured vkb complemented by a dynamic intraligamentary stabilization (DIS) and microfracture of the femoral notch or the gold standard, a ACL reconstruction.

Primary study parameters/outcome of the study:

Self-reported functional outcome at one-year follow post surgery measured by the IKDC 2000 subjective scale.

Secundary study parameters/outcome of the study (if applicable):

Secondaire eindpunten: Self-reported functional outcome at one-year follow post surgery measured by the IKDC 2000 subjective scale 6 weeks, 3,6 and 9 months, 2,5 and 10 years post surgery, self-reported disabilities (KOOS), level of physical activity (Tegner), satisfaction (VAS) as well as IKDC physical examination (clinimetretrics) 6 weeks, 3, 6 en 9 months, 1, 2, 5 and 10 years post surgery; instrumented anteroposterior laxity, leg symmetry index for jump tests as well as isokinetic quadriceps en hamstrings force 6 en 9 months, 1, 2, 5 en 10 years after surgery; radiologic signs of arthrosis 1,2 5 and 10 years post surgery; reruptures of the ACL within 10 years post surgery, classification rupture pattern peroperative.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Anterior Cruciate Ligament Injury
Intervention  ICMJE
  • Procedure: ACL Repair
    augmented suture of acute ACL rupture (<3 weeks after injury)
    Other Names:
    • Dynamic Intraligament Stabilization (DIS)
    • Augmented suture
  • Procedure: ACL reconstruction
    reconstruction hamstring autograft
    Other Names:
    • Primary ACL reconstruction
    • Autograft hamstring
    • All-inside
Study Arms  ICMJE
  • Active Comparator: ACL Reconstruction
    Primary reconstructive surgery of ACL with hamstring autograft (All-inside, Arthrex, Napels, Florida, USA)
    Intervention: Procedure: ACL reconstruction
  • Experimental: ACL Repair
    Primary augmented suture of ACL using Dynamic Intraligament Stabilization (DIS; Mathys Medical Bettlach, Switzerland)
    Intervention: Procedure: ACL Repair
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 4, 2014)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2029
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02310854
Other Study ID Numbers  ICMJE NL5011604414
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: to be determined yet
Responsible Party Rianne Huis in 't Veld, Orthopedisch Centrum Oost Nederland
Study Sponsor  ICMJE Orthopedisch Centrum Oost Nederland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: R.A.G Hoogeslag, MD OCON
PRS Account Orthopedisch Centrum Oost Nederland
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP