Status:
ACTIVE_NOT_RECRUITING
Acute Anterior Cruciate Ligament Rupture; RecOnsTruction Or Repair?
Lead Sponsor:
Orthopedisch Centrum Oost Nederland
Conditions:
Anterior Cruciate Ligament Injury
Eligibility:
All Genders
18-30 years
Phase:
NA
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 effectivene...
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-trau...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2029
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02310854
Start Date
November 1 2014
End Date
November 1 2029
Last Update
November 25 2025
Active Locations (1)
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1
Orthopedisch Centrum Oost Nederland /ZGT
Hengelo, Netherlands, 7555