Condition category
Musculoskeletal Diseases
Date applied
29/12/2016
Date assigned
16/02/2017
Last edited
13/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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). It is one of the four main ligaments within the knee, and the most common to be injured. ACL injuries usually happen in young athletes during high-intensity sports such as alpine skiing or soccer. Following an ACL injury, the knee joint itself can become unstable, which may prevent patients returning to their daily life activities. If this is the case, ACL reconstructive surgery is the best treatment option, which involves replacing the injured ACL with a tendon from elsewhere in the body, usually the quadriceps (thigh) and modifying the bone next to the joint to limit the motion of the joint (bone block). However, there is no clear evidence whether harvesting the tendon with or without a bone block of the knee cap has an impact on the clinical outcome. The aim of this study is to look at the outcomes for patients after ACL reconstruction surgery when bone block is also used to those for patients where bone block is not used.

Who can participate?
Adults who have an ACL injury that requires surgical treatment

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group undergo ACL reconstruction surgery using bone block. This involves modifying the bone next to the joint to limit motion. Those in the second group undergo ACL reconstruction surgery without using bone block. At the start of the study and then again after six, 12 and 24 months, participants in both groups have their knee stability and function assessed as well as completing questionnaires about their recovery and pain levels.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.

Where is the study run from?
Gelenkpunkt (Austria)

When is the study starting and how long is it expected to run for?
June 2016 to January 2020

Who is funding the study?
Gelenkpunkt (Austria)

Who is the main contact?
Miss Caroline Hepperger
c.hepperger@gelenkpunkt.com

Trial website

Contact information

Type

Scientific

Primary contact

Miss Caroline Hepperger

ORCID ID

Contact details

Tivoli Ost
Olympiastrasse 39
Innsbruck
6020
Austria
+43 512 397030
c.hepperger@gelenkpunkt.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

QT07102016

Study information

Scientific title

Clinical outcomes in anterior cruciate ligament reconstruction using quadriceps tendon autografts with or without bone block: a patient-blinded prospective randomized trial

Acronym

Study hypothesis

The anterior tibial translation in patients after anterior cruciate ligament reconstruction using a bone-free quadriceps tendon autograft is postoperatively not more than 1mm compared to patients operated with a quadriceps tendon-bone graft.

Ethics approval

Ethikkommission der Medizinischen Universität Innsbruck, 16/11/2016, ref: AN2016-0172 365/4.5

Study design

Patient-blinded prospective 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 the contact details below to request a patient information sheet

Condition

Anterior cruciate ligament injury

Intervention

Participants are randomised to one of two groups in a 1:1 ratio using the closed envelope method.

Group 1: Participants receive an anterior cruciate ligament reconstruction using a quadriceps tendon autograft without bone block. This involves harvesting a quadriceps tendon strip (7 x 0.5 cm) of the injuried knee.

Group 2: Participants receive an anterior cruciate ligament reconstruction using a quadriceps tendon autograft with bone block. This involves harvesting a bone block (1.5-2cm x 1cm) from the patella at the insertion of the quadriceps tendon. Further fixation and reconstruction of the anterior cruciate ligament is the same as in group 1

Follow up for all participants involves clinical and radiological evaluation and takes place 6, 12 and 24 months post-operatively.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Anterior knee stability is measured using the Lachman test at baseline, 6, 12 and 24 months post-operatively.

Secondary outcome measures

1. Pain is measured using the visual analogue scale (VAS) at baseline, 6, 12 and 24 months post-operatively
2. Patient-reported outcome is measured using the Lysholm and Tegner score (questionnaire) baseline, 6, 12 and 24 months post-operatively
3. Knee muscle strength is measured using a dynamometer at baseline, 6, 12 and 24 months post-operatively
4. Balance, speed and strength of the lower limb are measured using the "Back in action" test battery at baseline, 6, 12 and 24 months post-operatively
5. Osteoarthritis is measured using x-ray (Kellgren and Lawrence score) at 24 months post-operatively

Overall trial start date

01/06/2016

Overall trial end date

01/01/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18-60 years
2. Diagnosed with anterior knee instability requiring anterior cruciate ligament reconstruction in which the surgeon chose a QTB graft for reconstruction
3. Obtained written consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Patient prefers one surgical technique over the other or does not consent to a surgical treatment at all
2. Pre-existing ipsilateral knee pathology
3. Bilateral ACL injuries
4. Chronic ACL injuries older than 6 months
5. Multiligament injuries (in combination with posterior cruciate or collateral ligament injuries grade II or higher)
6. Chondral injuries (lesions greater than 2cm2 with a depth of more than 50% of the cartilage thickness)
7. Meniscal injuries (involving more than 2/3 of the meniscus or need for meniscus repair)
8. Infection
9. Systematic disease
10. Lack of compliance
11. Chronic alcohol or drug abuse

Recruitment start date

01/01/2017

Recruitment end date

01/01/2018

Locations

Countries of recruitment

Austria

Trial participating centre

Gelenkpunkt
Tivoli Ost Olympiastrasse 39
Innsbruck
6020
Austria

Sponsor information

Organisation

Gelenkpunkt

Sponsor details

Tivoli Ost
Olympiastrasse 39
Innsbruck
6020
Austria
+43 512 397030
c.hepperger@gelenkpunkt.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Gelenkpunkt

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal in 2021.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Caroline Hepperger (c.hepperger@gelenkpunkt.com)

Intention to publish date

31/12/2021

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes