A study of three different fixation methods in anterior cruciate ligament reconstruction

ISRCTN	ISRCTN34011837
DOI	https://doi.org/10.1186/ISRCTN34011837
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Orton Orthopaedic Hospital
Funder	Sosiaali- ja Terveysministeriö

Submission date: 02/04/2020
Registration date: 17/04/2020
Last edited: 09/02/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

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 joining the thigh bone to the shin bone at the knee joint. ACL injuries can be treated with reconstructive surgery removing what remains of the torn ligament and replacing it with a tendon from another area of the leg, such as the hamstring. The aim of this study is to compare the results of hamstring tendon ACL reconstructions with different fixation methods.

Who can participate?
Patients aged 18 to 50 with ACL injuries

What does the study involve?
Participants are randomly allocated into four different groups to be treated with different fixation methods. Hamstring tendons are used as a graft with every patient. Participants are followed up for 5 years to assess the stability of the operated knee.

What are the possible benefits and risks of participating?
Possible benefits are a stable knee. Possible risks are operative risks including infection.

Where is the study run from?
Orton Orthopaedic Hospital (Finland)

When is the study starting and how long is it expected to run for?
June 2001 to January 2016

Who is funding the study?
This work was supported by Orton research grants by the Ministry of Social Affairs and Health (Finland)

Who is the main contact?
Dr Leena Metso
leena.metso@fimnet.fi

Contact information

Dr Leena Metso
Scientific

Työpajankatu 14 A
Helsinki
00580
Finland

ORCID ID	0000-0003-2875-6478
Phone	+358 (0)406700094
Email	leena.metso@fimnet.fi

Study information

Primary study design	Interventional
Study design	Randomized controlled clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A prospective randomized study of three hamstring fixation devices with a minimum 5-year follow-up
Study objectives	After 5 years of follow-up there is no difference in the outcome after either cross-pin or absorbable interference screw fixation in ACL (anterior cruciate ligament) reconstruction with hamstring tendon autografts.
Ethics approval(s)	Approved 11/11/2015, The Hospital District of Helsinki and Uusimaa Operative Ethics Committee (Tynnyrintekijänkatu 1 C, Helsinki, Finland; +358 (0)50 428 7838; keskuskirjaamo@hus.fi), ref: 364/13/03/02/2015. TMK02 §219
Health condition(s) or problem(s) studied	Anterior cruciate ligament injury
Intervention	Randomization will be done by sealed, numbered envelopes containing information of the treatment group. The study is a comparison of results of hamstring tendon ACL reconstructions with different fixation methods: Group I: femoral Rigidfix cross-pins and a tibial expansion sheath with a tapered expansion screw Intrafix Group II: femoral Rigidfix and tibial interference screw fixation with BioScrew Group III: femoral BioScrew and tibial Intrafix fixation Group IV: BioScrew fixation into both tunnels (tibia, femur) Total duration of the treatment will be optimized for the patient's needs - the length of physiotherapeutic assistance some 6 weeks. The follow up is planned up to 5 years postoperatively. The last patients will be telephoned to collect the subjective results during winter 2015-2016.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Stability of the operated knee measured with Lachman, pivot-shift, and anteroposterior knee laxity tests, preoperative and at 1- and 2-year follow-ups
Key secondary outcome measure(s)	Patient satisfaction measured with Tegner, Lysholm, patellofemoral scores and IKDC questionnaires, preoperative and at 1- and 2-year follow-ups
Completion date	31/01/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Total final enrolment	120
Key inclusion criteria	1. Fresh or chronic injury (less than 5 years old) 2. Unilateral ACL tears 3. Female or male patient 4. Age range of 18 to 50 years
Key exclusion criteria	1. Interval between the injury and surgery over 5 years 2. ACL revision procedure 3. Concomitant grade 2-3 collateral or posterior cruciate ligament tear 4. Peripherally detached meniscal tear to be repaired 5. Outerbridge 3 to 4 chondral damage 6. Arthrosis of the knee
Date of first enrolment	01/08/2001
Date of final enrolment	31/08/2004

Locations

Countries of recruitment

Finland

Study participating centre

Orton Orthopaedic Hospital

Tenholantie 10
Helsinki
00280
Finland

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Arsi Harilainen (arsi.harilainen@orton.fi).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	2 year follow-up results	01/04/2009		Yes	No
Results article	5 year follow-up results	30/06/2022	01/07/2022	Yes	No
Results article	clinical follow up results for patient satifaction secondary outcomes	06/01/2024	09/02/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

09/02/2024: Publication reference added.
01/07/2022: Publication reference added.
17/04/2020: Internal review.
06/04/2020: Trial's existence confirmed by Hospital District of Helsinki and Uusimaa Operative Ethics Committee.