A study of three different fixation methods in anterior cruciate ligament reconstruction
| ISRCTN | ISRCTN34011837 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34011837 |
- 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
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
Scientific
Työpajankatu 14 A
Helsinki
00580
Finland
 ORCID ID |
0000-0003-2875-6478 |
|---|---|
| Phone | +358 (0)406700094 |
| leena.metso@fimnet.fi |
Study information
| Study design | Randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a 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 | Stability of the operated knee measured with Lachman, pivot-shift, and anteroposterior knee laxity tests, preoperative and at 1- and 2-year follow-ups |
| Secondary outcome measures | Patient satisfaction measured with Tegner, Lysholm, patellofemoral scores and IKDC questionnaires, preoperative and at 1- and 2-year follow-ups |
| Overall study start date | 01/06/2001 |
| Completion date | 31/01/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Target number of participants was 120, divided into 4 groups of 30 patients each |
| 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
Helsinki
00280
Finland
Sponsor information
Hospital/treatment centre
Tenholantie 10
Helsinki
00280
Finland
| Phone | +358-9-4748 2705 |
|---|---|
| leena.ristolainen@orton.fi | |
| Website | http://www.orton.fi |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/04/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| 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 |
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.
