Plain English Summary
Background and study aims
The anterior cruciate ligament (ACL) is a tough band of tissue in the middle of the knee, preventing the shin bone (tibia) from sliding out in front of the thigh bone (femur). ACL injuries are one of the most common types of knee injuries, which usually occur during high-intensity sports such as football or basketball. They happen when the ACL in the knee is over-stretched or torn, which causes the knee to become very unstable and can make some types of movement very difficult. There are various surgical and non-surgical treatments available for people with an ACL injury, however when the tear is particularly bad, reconstructive surgery is often recommended. In this type of surgery, the doctor will replace the torn ligament with living tissue from elsewhere in the body (autograft). In most cases, the graft is taken from the hamstring tendons at the back of the thigh, however in some cases, a quadriceps tendon which runs from the kneecap into the thigh. The aim of this study is to compare the level of pain after surgery, and the short-term results for these two types of graft.
Who can participate?
Patients with ACL injury between 16-50 years of age.
What does the study involve?
Patients who are suitable for ACL repair surgery are randomly assigned into two groups. The first group receive a free quadriceps tendon autograft (taken from the same knee, just above the kneecap). The second group receive a quadrupled hamstring autograft (taken from the same knee, just beneath the kneecap). All patients are started on the same pain-relief regime one hour after surgery, and are asked to rate their pain intensity using a scale of 0-100 (with 0 being no pain, and 100 being severe pain) within the first 12 hours post-op, between 12-24 hours post-op, and between 24-48 hours post-op. The patients are also asked to complete questionnaires about their recovery after 6 weeks, 3 months, and 6 months after surgery.
What are the possible benefits and risks of participating?
There is no real benefit for participants, other than receiving treatment to help their condition. The risks of participating are the general risks surgical complications (infection, bleeding, surgical wound complication).
Where is the study run from?
University of Medicine and Pharmacy Cluj-Napoca (Romania)
When is the study starting and how long is it expected to run for?
October 2013 to May 2015
Who is funding the study?
University of Medicine and Pharmacy Cluj-Napoca (Romania)
Who is the main contact?
Mr Cristian Buescu
Trial website
Contact information
Type
Public
Primary contact
Mr Cristian Buescu
ORCID ID
http://orcid.org/0000-0003-0091-5975
Contact details
40 Campului st
ap 87
Cluj-Napoca
400651
Romania
Additional identifiers
EudraCT number
2015-003367-11
ClinicalTrials.gov number
Protocol/serial number
298
Study information
Scientific title
Anterior cruciate ligament reconstruction with free quadriceps versus quadrupled hamstring autografts
Acronym
Study hypothesis
The use of free quadriceps (FQ) will be less painful and will reduce analgesic use compared to semitendinos and gracilis (STG) in anterior cruciate ligament reconstruction, and that there will be no significant difference in short-term clinical results.
Ethics approval
Iuliu Hatieganu University of Medicine and Pharmacy Ethics Committee, 29/07/2014, ref: 298/28.07.2014
Study design
Prospective longitudinal randomized parallel trial.
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Anterior cruciate ligament chronic injury
Intervention
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).
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
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).
Secondary outcome measures
Follow-ups made at 6 weeks, 3 and 6 months after surgery with clinical assessment and Tegner and Lysholm self-evaluation questionnaires.
Overall trial start date
20/10/2013
Overall trial end date
20/05/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged between 16-50 years
2. Schedules for ACL repair.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60 patients: 30 in each group
Participant 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.
Recruitment start date
15/11/2013
Recruitment end date
20/11/2014
Locations
Countries of recruitment
Romania
Trial participating centre
University of Medicine and Pharmacy Cluj-Napoca
Orthopedics and Trauma Clinic
Cluj-Napoca
400132
Romania
Sponsor information
Organisation
University of Medicine and Pharmacy Cluj-Napoca
Sponsor details
8 Victor Babes st
Cluj-Napoca
400012
Romania
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Medicine and Pharmacy Cluj-Napoca
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Clinical Emergency County Hospital of Cluj
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
As data collection is finished, the article is prepared for submission to BMC: Journal of Orthopedic Surgery and Research.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28242265