Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Leena Metso
ORCID ID
http://orcid.org/0000-0003-2875-6478
Contact details
Työpajankatu 14 A
Helsinki
00580
Finland
+358 406700094
leena.metso@fimnet.fi
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
9750/44
Study information
Scientific title
A retrospective comparison of clinical results of anteromedial and transtibial femoral tunnel drilling in ACL reconstruction
Acronym
Study hypothesis
Is there a clinical difference in results between anteromedial and transtibial femoral drilling in the reconstruction of anterior cruciate ligament?
Ethics approval
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
Study design
Retrospective case control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
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
Phase
Drug names
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 trial start date
01/01/2006
Overall trial end date
31/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Mixed
Gender
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
Participant exclusion criteria
1. PCL reconstruction done at the same time or previously
2. Revision ACL surgery (exclusion from the final data analysis)
Recruitment start date
15/05/1990
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Finland
Trial participating centre
Hospital Orton, Invalid Foundation
Tenholantie 10
Helsinki
00280
Finland
Sponsor information
Organisation
Invalidisäätiö
Sponsor details
ORTON Orthopaedic Hospital
Invalid Foundation
Tenholantie 10
Helsinki
00280
Finland
+358947481
leena.ristolainen@orton.fi
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
This work was supported by Orton research-grants by the Ministry of Social Affairs and Health, Finland.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
This article will be sent for evaluation in an orthopaedic journal in January 2020.
IPD sharing statement:
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.
Intention to publish date
16/01/2020
Participant level data
Available on request
Basic results (scientific)
Publication list