Results of tape locking screw device used in anterior cruciate ligament reconstruction: 2 years follow-up
| ISRCTN | ISRCTN20079062 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20079062 |
- Submission date
- 02/04/2020
- Registration date
- 29/04/2020
- Last edited
- 29/04/2020
- 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 collect clinical follow-up data of the Tape Locking Screw™ (TLS™) technique in ACL reconstruction.
Who can participate?
Patients with an ACL injury
What does the study involve?
All patients undergo surgery with the Tape Locking Screw (TLS™) technique. There are clinical follow-ups at 1 and 2 years after the surgery, patients also filled in questionnaires.
What are the possible benefits and risks of participating?
Possible benefits include 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?
September 2007 to July 2012
Who is funding the study?
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 | Single-centre prospective clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| 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 | Results of Tape Locking Screw™ in anterior cruciate ligament reconstruction: 2 years follow-up |
| Study objectives | This study is collecting clinical follow-up data of the Tape Locking Screw™ (TLS™) technique. |
| 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 | 137 consecutive patients with an ACL injury were enrolled to be operated on with the TLS™ technique. Every ACL reconstruction was performed by the same orthopedic surgeon (AH) during the time period of November 2007 to July 2012. The results of Lysholm score, Tegner score, laxity, Lachmann test and pivot-shift tests were recorded at 1- and 2- years of follow-up. Patients were allocated consecutively in a single-centre hospital Orton in Helsinki Finland between November 2007 and July 2012. Clinical controls were at 1 and 2 years postoperatively. |
| 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 | 30/09/2007 |
| Completion date | 30/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | The minimal target recruitment number was 120 patients |
| Total final enrolment | 137 |
| Key inclusion criteria | Patients with ACL injury |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/11/2007 |
| Date of final enrolment | 15/07/2012 |
Locations
Countries of recruitment
- Finland
Study participating centre
Helsinki
00280
Finland
Sponsor information
Hospital/treatment centre
Tenholantie 10
Helsinki
00280
Finland
| Phone | +358 (0)9 47481 |
|---|---|
| leena.ristolainen@orton.fi | |
| Website | http://www.orton.fi |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Ministry of Social Affairs and Health, Social- och Hälsovårdsministeriet
- Location
- Finland
Results and Publications
| Intention to publish date | 31/05/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in spring 2020. |
| 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). |
Editorial Notes
06/04/2020: Trial's existence confirmed by Hospital District of Helsinki and Uusimaa Operative Ethics Committee.
