Comparison of clinical results of anteromedial and transtibial femoral tunnel drilling techniques in knee reconstruction surgery
| ISRCTN | ISRCTN16407730 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16407730 |
| Secondary identifying numbers | 9750/44 |
- Submission date
- 31/12/2019
- Registration date
- 09/01/2020
- Last edited
- 05/06/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Anterior cruciate ligament (ACL) reconstruction is a type of knee surgery to replace the ACL – one of the main ligaments in the knee. The ACL connects the thigh bone to the shin bone, and along with other ligaments in the knee, keeps the knee stable. A number of methods can be used to reconstruct an anterior cruciate ligament (ACL). The most common method is to use a tendon from elsewhere in the body to replace the ACL. The surgeon needs to drill a tunnel in the bone to pass the new tissue through.
The aim of this study is to compare two different drilling techniques in terms of the long term outcome on knee function.
Who can participate?
Patients who underwent knee reconstructive surgery at Orton Hospital in Helsinki Finland between May 1990 and December 2011
What does the study involve?
Retrospective data is gathered from patient records regarding the clinical outcomes of two different surgical techniques for knee reconstruction (anteromedial drilling and transtibial drilling).
What are the possible benefits and risks of participating?
None
Where is the study run from?
Hospital Orton, Invalid Foundation, Helsinki, Finland.
When is the study starting and how long is it expected to run for?
January 2006 to December 2013
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 406700094 |
| leena.metso@fimnet.fi |
Study information
| Study design | Retrospective case control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control 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 | A retrospective comparison of clinical results of anteromedial and transtibial femoral tunnel drilling in ACL reconstruction |
| Study objectives | Is there a clinical difference in results between anteromedial and transtibial femoral drilling in the reconstruction of anterior cruciate ligament? |
| 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 rupture |
| Intervention | Is there a clinical difference between anteromedial and transtibial tunnel drilling results in anterior cruciate ligament reconstruction at two year follow up. For this study we chose retrospectively 300 consecutive patients admitted to Orton Hospital, Helsinki Finland. They had been divided into two groups of 150 patients. The evaluation methods were clinical examination, knee scores (Lysholm, Tegner, IKDC) and instrumented laxity measurements (KT-2000™). ACL ruptures were treated with an operation. 150 patients with anteromedial (AM) drilling and 150 with transtibial (TT) drilling. In the AM group the reconstructions were performed using semitendinosus graft with Tape Locking Screw (TLS™) technique or Retrobutton™ femoral and BioScrew™ tibial fixation with a semitendinosus-gracilis graft. In the TT group the fixation method used was Rigidfix™ femoral and Intrafix tibial fixation. Patients were allocated consecutively in a single-centre hospital Orton in Helsinki Finland between May 1990 and December 2011. Clinical controls were at 1 and 2 years postoperatively. This is a retrospective study. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Recovery of knee function measured at one and two years post-operatively using: 1. Clinical examination 2. Knee scores (Lysholm, Tegner, IKDC) 3. Instrumented laxity measurements (KT-2000™) |
| Secondary outcome measures | Patient satisfaction measured using inteview at one and two years post-operatively |
| Overall study start date | 01/01/2006 |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | Total number of patients recruited was 300. Revision ACL reconstruction was performed in 18 patients in the anteromedial group and in 17 in the transtibial group. These patients were excluded from the final evaluation leaving 132 patients in the anteromedial group and 133 patients in the transtibial group. |
| Total final enrolment | 265 |
| Key inclusion criteria | 1. Male and female gender, no data of the percentage is collected 2. No limitations, mean age of the patients was 34 years (12-64 years) 3. ACL reconstruction performed with meniscal and collateral surgery done if needed |
| Key exclusion criteria | 1. PCL reconstruction done at the same time or previously 2. Revision ACL surgery (exclusion from the final data analysis) |
| Date of first enrolment | 15/05/1990 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Finland
Study participating centre
Helsinki
00280
Finland
Sponsor information
Hospital/treatment centre
ORTON Orthopaedic Hospital, Invalid Foundation
Tenholantie 10
Helsinki
00280
Finland
| Phone | +358947481 |
|---|---|
| leena.ristolainen@orton.fi | |
| Website | https://www.orton.fi |
"ROR" |
https://ror.org/020vv3w23 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 16/01/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | This article will be sent for evaluation in an orthopaedic journal in January 2020. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Data is available from Arsi Harilainen, arsi.harilainen@orton.fi, type of data: BMDP statistics, data available at any time for 10 years. Access considered upon request. Raw data can be provided. Sharing the data with the third party has not been discussed with participants. Data is anonymised and there are no legal restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/06/2020 | 05/06/2020 | Yes | No |
Editorial Notes
05/06/2020: Publication reference added.
09/01/2020: Trial’s existence confirmed by The Hospital District of Helsinki and Uusimaa Operative Ethics Committee
