CompletedNot Applicable

Acute Anterior Cruciate Ligament Rupture; RecOnsTruction Or Repair?

Netherlands48 participantsStarted 2014-11

Plain-language 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.

Who can participate

Age range

18 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

IKDC 2000 subjective knee evaluation form

Timeframe: baseline, 12 months post surgery

Trial details

NCT IDNCT02310854

SponsorOrthopedisch Centrum Oost Nederland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04

View on ClinicalTrials.gov More Anterior Cruciate Ligament Injury trials