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Acute anterior cruciate ligament rupture: RecOnsTruction Or Repair?

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45094
Enrollment
48
Registered
2014-09-30
Start date
2014-10-30
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

voorste kruisband chirurgie anterior cruciate ligament rupture

Interventions

n=48 patients will participate in the current study. n=33 at OCON and n=15 at HAGA. Patients will be assigned to a suture repair of the ruptured vkb complemented by a dynamic intraligamentary stabil

Sponsors

Ziekenhuisgroep Twente
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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; biomechanical parameters jump tests with 3D motion sensors (hip flexion-, knee flexion- and knee varus angles at initial landing contact) 1 and 2 years after surgery and a sport-specific fatigue test with electromyography (EMG) and 3D motion sensors (a repeated measures ANOVA with Bonferroni post-hoc analysis of the quadriceps/hamstring activation ratio, hip flexion-, knee flexion- and knee varus angles) between 10-18 months 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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)