Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01025895
NCT01025895UnknownPhase 4

Anterior Cruciate Ligament (ACL) Reconstruction: Single Bundle Versus Double Bundle

Assaf-Harofeh Medical Center0 sites60 target enrollmentStarted: January 2010Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 4
Enrollment
60
Primary Endpoint
WOMAC, VAS, SF-36, Lisholm, Knee society score, isokinetic muscle strength testing, Single HOP test , Tripple Hop Test
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

ACL tear is a common injury among athletes. The recommended treatment includes reconstruction of the ligament. The common reconstruction technique is single bundle reconstruction. However, this technique does not simulate the natural structure of the ligament. The purpose of the study is to compare between the common procedure, Single Bundle reconstruction with the Double Bundle reconstruction technique.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment

Eligibility Criteria

Ages
16 Years to 40 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •knee instability with a history of ACL tear
  • •diagnosed ACL tear according to MRI
  • •age range 16-40.

Exclusion Criteria

  • •previous surgery in the knees
  • •multiple ligament raptures
  • •partial ACL tear
  • •severe cartilage degeneration
  • •genovaruse/genovalgus
  • •thin hamstrings tendons
  • •oper epiphysis in the knee joint
  • •patient with muscle/neurological problem that increases the tendency to fall

Outcomes

Primary Outcomes

WOMAC, VAS, SF-36, Lisholm, Knee society score, isokinetic muscle strength testing, Single HOP test , Tripple Hop Test

Time Frame: pre-op. 1 day post op., 7-14 days post op., 6 weeks post op., 12 weeks post op., 26 weeks post op., 1 year post op., 2 years post op.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov

Similar Trials

Enrolling By Invitation
Not Applicable
Reconstruction of the ACL With QT Graft With Bone Plug vs BPTBAnterior Cruciate Ligament Rupture
NCT06189573Instituto Nacional de Rehabilitacion80
Active, not recruiting
Not Applicable
STABILITY 2: Anterior Cruciate Ligament Reconstruction +/- Lateral Tenodesis With Patellar vs Quad TendonAnterior Cruciate Ligament ReconstructionJoint InstabilityAnterior Cruciate Ligament Injury
NCT03935750University of Pittsburgh1,272
Recruiting
Not Applicable
Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Bone AutograftAnterior Cruciate Ligament TearAnterior Cruciate Ligament InjuriesAnterior Cruciate Ligament Rupture
NCT05673356Artromedical Konrad Malinowski Clinic25
Recruiting
Not Applicable
Arthroscopic Anterior Cruciate Ligament Repair Versus Reconstruction for Acute Anterior Cruciate Ligament InjuryAnterior Cruciate Ligament Injuries
NCT05584020Second Affiliated Hospital, School of Medicine, Zhejiang University140
Completed
Not Applicable
The Effects of Remnant-Preserving Anterior Cruciate Ligament Reconstruction on Proprioception and FunctionalityAnterior Cruciate Ligament Rupture
NCT05057442Acibadem University65