Acute Anterior Cruciate Ligament Rupture; RecOnsTruction Or Repair?

NCT02310854 | Completed DMC

• 1 other identifier: NL5011604414
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Anterior Cruciate Ligament Injury

Keywords

anterior cruciate ligament rupture; autograft; reconstruction; orthopedic surgery; dynamic intraligament stabilization

Outcome Measures

Primary Outcomes (1)

• IKDC 2000 subjective knee evaluation form

  questionniare/self-reported functional limitations in activitities of daily living and/or sports activities

  baseline, 12 months post surgery

Secondary Outcomes (6)

• IKDC 2000 subjective knee evaluation form

  baseline, 6 weeks, 3-6-9-12 months, 2-5-10 years post surgery

• IKDC 2000 objective knee evaluation form

  baseline, 6 weeks, 3-6-9-12 months, 2-5-10 years post surgery

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  baseline, 6 weeks, 3-6-9-12 months, 2-5-10 years post surgery

• Tegner Activity Level Scale

  baseline, 6 weeks, 3-6-9-12 months, 2-5-10 years post surgery

• Instrumented anteroposterior laxity

  baseline, 6 weeks, 3-6-9-12 months, 2-5-10 years post surgery

Other Outcomes (5)

• Reinjuries

  up till 10 years post surgery

• workability

  baseline, 6 weeks, 3-6-9-12 months, 2-5-10 years post surgery

• Classification of type of rupture of the ACL

  during surgery

Study Arms (2)

ACL Reconstruction

ACTIVE COMPARATOR

Primary reconstructive surgery of ACL with hamstring autograft (All-inside, Arthrex, Napels, Florida, USA)

Procedure: ACL reconstruction

ACL Repair

EXPERIMENTAL

Primary augmented suture of ACL using Dynamic Intraligament Stabilization (DIS; Mathys Medical Bettlach, Switzerland)

Procedure: ACL Repair

Interventions

ACL Repair PROCEDURE

augmented suture of acute ACL rupture (\<3 weeks after injury)

Also known as: Dynamic Intraligament Stabilization (DIS), Augmented suture

ACL Repair

ACL reconstruction PROCEDURE

reconstruction hamstring autograft

Also known as: Primary ACL reconstruction, Autograft hamstring, All-inside

ACL Reconstruction

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Sportive, active patient (Tegner score =/\>5)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orthopedisch Centrum Oost Nederland: lead

Study Sites (1)

Orthopedisch Centrum Oost Nederland /ZGT

Hengelo, 7555, Netherlands

Location

Related Publications (2)

• Hoogeslag RAG, Brouwer RW, Boer BC, de Vries AJ, Huis In 't Veld R. Acute Anterior Cruciate Ligament Rupture: Repair or Reconstruction? Two-Year Results of a Randomized Controlled Clinical Trial. Am J Sports Med. 2019 Mar;47(3):567-577. doi: 10.1177/0363546519825878.

  PMID: 30822124 DERIVED

• Boer BC, Hoogeslag RAG, Brouwer RW, Demmer A, Huis In 't Veld RMHA. Self-reported functional recovery after reconstruction versus repair in acute anterior cruciate ligament rupture (ROTOR): a randomized controlled clinical trial. BMC Musculoskelet Disord. 2018 Apr 20;19(1):127. doi: 10.1186/s12891-018-2028-4.

  PMID: 29678170 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• R.A.G Hoogeslag, MD

  OCON

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 8, 2014
• Study Start: November 1, 2014
• Primary Completion: April 1, 2026
• Study Completion: April 17, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

NL (1)