Is quadriceps tendon a better choice than hamstring tendons for repairing anterior cruciate ligament lesion?

ISRCTN	ISRCTN12967309
DOI	https://doi.org/10.1186/ISRCTN12967309
EudraCT/CTIS number	2015-003367-11
Secondary identifying numbers	298

Submission date: 18/08/2015
Registration date: 25/08/2015
Last edited: 04/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Mr Cristian Buescu
Public

40 Campului st, ap 87
Cluj-Napoca
400651
Romania

ORCID ID	0000-0003-0091-5975

Study information

Study design	Prospective longitudinal randomized parallel trial.
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Anterior cruciate ligament reconstruction with free quadriceps versus quadrupled hamstring autografts
Study objectives	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(s)	Iuliu Hatieganu University of Medicine and Pharmacy Ethics Committee, 29/07/2014, ref: 298/28.07.2014
Health condition(s) or problem(s) studied	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
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 study start date	20/10/2013
Completion date	20/05/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	60 patients: 30 in each group
Key inclusion criteria	1. Aged between 16-50 years 2. Schedules for ACL repair.
Key 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.
Date of first enrolment	15/11/2013
Date of final enrolment	20/11/2014

Locations

Countries of recruitment

Romania

Study participating centre

University of Medicine and Pharmacy Cluj-Napoca

Orthopedics and Trauma Clinic
Cluj-Napoca
400132
Romania

Sponsor information

University of Medicine and Pharmacy Cluj-Napoca
University/education

8 Victor Babes st
Cluj-Napoca
400012
Romania

Website	www.umfcluj.ro
"ROR"	https://ror.org/051h0cw83

Funders

Funder type

University/education

University of Medicine and Pharmacy Cluj-Napoca

No information available

Clinical Emergency County Hospital of Cluj

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	As data collection is finished, the article is prepared for submission to BMC: Journal of Orthopedic Surgery and Research.
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2017		Yes	No

Editorial Notes

04/02/2019: Publication reference added.