Results after anterior cruciate ligament reconstruction using the quadriceps tendon with or without a bone block

• Register: ISRCTN
• Last refreshed on: 26 February 2018
• Main ID: ISRCTN95543927
• Date of registration: 16/02/2017
• Prospective Registration: No
• Primary sponsor: Gelenkpunkt
• Public title: Results after anterior cruciate ligament reconstruction using the quadriceps tendon with or without a bone block
• Scientific title: Clinical outcomes in anterior cruciate ligament reconstruction using quadriceps tendon autografts with or without bone block: a patient-blinded prospective randomized trial
• Date of first enrolment: 01/01/2017
• Target sample size: 50
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN95543927
• Study type: Interventional
• Study design: Patient-blinded prospective randomized parallel trial (Treatment)

Countries of recruitment

Austria

Contacts

• Name: Caroline Hepperger

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Anterior cruciate ligament injury
Musculoskeletal Diseases
Anterior cruciate ligament injury

Intervention(s)

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.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

QT07102016

Source(s) of Monetary Support

Gelenkpunkt

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 01/01/2020