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.
Investigators
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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