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Clinical Trials/NL-OMON45094
NL-OMON45094
Completed
Not Applicable

Acute anterior cruciate ligament rupture: RecOnsTruction Or Repair? - ROTOR study

Ziekenhuisgroep Twente0 sites48 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Ziekenhuisgroep Twente
Enrollment
48
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Ziekenhuisgroep Twente

Eligibility 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

Outcomes

Primary Outcomes

Not specified

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