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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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4 March 2019 |
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Main ID: |
ISRCTN12967309 |
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Date of registration:
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25/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Is quadriceps tendon a better choice than hamstring tendons for repairing anterior cruciate ligament lesion?
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Scientific title:
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Anterior cruciate ligament reconstruction with free quadriceps versus quadrupled hamstring autografts |
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Date of first enrolment:
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15/11/2013 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN12967309 |
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Study type:
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Interventional |
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Study design:
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Prospective longitudinal randomized parallel trial. (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Romania
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Cristian
Buescu |
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Address:
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40 Campului st, ap 87
400651
Cluj-Napoca
Romania |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Aged between 16-50 years
2. Schedules for ACL repair.
Exclusion criteria:
1. Lesions older than 2 years, associated meniscus or other ligament lesion that required surgical management
2. Previous surgeries on the same knee.
3. Patients with chronic pain or hepatic impairment
4. Alcoholics or drug abusers.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anterior cruciate ligament chronic injury
Musculoskeletal Diseases
Anterior cruciate ligament chronic injury
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Intervention(s)
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We performed arthroscopic anatomic single-bundle anterior cruciate ligament reconstruction using either free quadriceps tendon autograft or quadrupled hamstring autograft (semitendinosus and gracilis tendons) .
A multimodal analgesic postoperative regimen was started 1 hour after surgery and consisted of acetaminophen (Paracetamol, Terapia-Ranbaxy, Cluj-Napoca, Romania) 500 mg per os (po) and ketorolac tromethamina (Ketorol, Dr. Reddy's Lab. (UK) LTD.) 15mg intravenous (iv) every 8 hours, for the first 49 postoperative hours. Rescue analgesia was provided with tramadol (Aliud® Pharma GmbH & Co. KG, Gottlieb-Daimler-Str. 19, D-89150 Laichingen, Germany) 30 mg iv bolus when patients declared pain scores of 30 or more on the Visual Analog Scale (VAS).
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Primary Outcome(s)
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1. Postoperative pain intensity was evaluated using the Visual Analog Scale, ranging from 0 to 100, with 0 to 30 considered mild pain, 30 to 70 moderate pain and over 70, severe pain.
2. Time to the first rescue analgesic requirement, the number of doses of tramadol and the pain score were recorded. The postoperative period was split three-way (first 12 hours post-op, 12-24 hours post-op, 24-48 hours post-op).
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Secondary Outcome(s)
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Follow-ups made at 6 weeks, 3 and 6 months after surgery with clinical assessment and Tegner and Lysholm self-evaluation questionnaires.
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Secondary ID(s)
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2015-003367-11
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298
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Source(s) of Monetary Support
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University of Medicine and Pharmacy Cluj-Napoca, Clinical Emergency County Hospital of Cluj
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Ethics review
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Status:
Approval date:
Contact:
Iuliu Hatieganu University of Medicine and Pharmacy Ethics Committee, 29/07/2014, ref: 298/28.07.2014
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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20/05/2015 |
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URL:
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