- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00338663
A Study on Knee Immobilization and Pain Levels After an Anterior Cruciate Ligament (ACL) Reconstruction Surgery
The Effect of Knee Immobilization on Postoperative Pain Following an Anterior Cruciate Ligament (ACL) Reconstruction: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alberta
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Banff, Alberta, Canada, T1L 1B3
- Banff Sport Medicine Clinic
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Calgary, Alberta, Canada, T2G 5B6
- Lindsay Park Sports Injury Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical: Patients' aged 18-40, ACL deficiency as determined by MRI or physical exam (positive lachmann and pivot shift tests) resulting in giving way episodes (acute or chronic) unresponsive to non-operative management and therefore requiring primary ACL reconstruction.
- Arthroscopic: Concomitant meniscal resection.
Exclusion Criteria:
- Clinical: Previous surgery on either knee (not including a diagnostic arthroscopy arthroscopy or simple partial meniscectomy,) Concomitant lower extremity fracture, Ipsilateral collateral ligament injury within past 3 months, Time from ACL injury less than 6 weeks, Allergy/intolerance to Tylenol 3 with codeine and to Percocet, Third Party or Medical Legal.
- Radiological: Skeletal immaturity (open growth plates).
- Arthroscopic/surgical: Concomitant posterior cruciate ligament or collateral ligament repairs, Osteochondral lesions requiring microfracture, Meniscal repair, Patients not having both their semitendinosus and gracilis harvested.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Patient self-assessed pain levels using an unmarked zero to one hundred mm visual analog scale (VAS) at forty eight hours postoperative.
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Secondary Outcome Measures
Outcome Measure |
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Patient self-assessed pain levels using an unmarked zero to one hundred mm visual analog scale (VAS) at seven and fourteen days postoperative.
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Analgesic type and time taken will be self reported by the patient at each VAS entry.
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Range of motion including both flexion and extension will be assessed at fourteen days postoperative by the surgeon.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laurie A Hiemstra, MD, PhD, Lifemark Health Research Group
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- E-20041
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anterior Cruciate Ligament Reconstruction
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Federal University of Health Science of Porto AlegreNot yet recruitingAnterior Cruciate Ligament Reconstruction | Anterior Cruciate Ligament Reconstruction RehabilitationBrazil
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University of Sao Paulo General HospitalUnknownAnterior Cruciate Ligament Reconstruction | Rehabilitation | Anterolateral Ligament ReconstructionBrazil
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University of ÉvoraFundação para a Ciência e a Tecnologia; Comprehensive Health Research Centre; Hospital da Misericórdia de ÉvoraNot yet recruitingAnterior Cruciate Ligament Reconstruction
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China Medical University HospitalRecruitingAnterior Cruciate Ligament ReconstructionTaiwan
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University Medical Centre MariborActive, not recruitingAnterior Cruciate Ligament ReconstructionSlovenia
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Istituto Ortopedico RizzoliMinistry of Health, ItalyCompletedAnterior Cruciate Ligament ReconstructionItaly
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Instituto Nacional de RehabilitacionUniversidad Nacional Autonoma de MexicoActive, not recruiting
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Laval UniversityOrdre Professionnel de la Physiothérapie du Québec (OPPQ)CompletedANTERIOR CRUCIATE LIGAMENT RECONSTRUCTIONCanada
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University of PittsburghWithdrawnAnterior Cruciate Ligament ReconstructionUnited States
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University of North Carolina, Chapel HillCompletedAnterior Cruciate Ligament Reconstruction
Clinical Trials on knee immobilization splint
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University of Sao PauloCompletedRadius Fracture DistalBrazil
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Rush University Medical CenterNot yet recruitingACL Injury | ACL Tear | Arthrofibrosis
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McMaster UniversityCompletedMuscle Atrophy | Disuse Atrophy (Muscle) of Lower LegCanada
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University of Sao Paulo General HospitalUnknownAnterior Cruciate Ligament Reconstruction | Rehabilitation | Anterolateral Ligament ReconstructionBrazil
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Sorlandet Hospital HFOslo University Hospital; Helse Stavanger HF; Haukeland University Hospital; St... and other collaboratorsCompleted
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Hospital Dr. Fernando Mauro Pires da RochaFederal University of São PauloCompletedDistal Radius FractureBrazil
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University of TromsoSuspendedDistal Radius Fracture | Colles' FractureNorway
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Maastricht University Medical CenterCompleted
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Maastricht University Medical CenterCompletedImmobilization | Neuromuscular Electrical Stimulation | Disuse AtrophyNetherlands