Condition category
Musculoskeletal Diseases
Date applied
31/12/2019
Date assigned
09/01/2020
Last edited
09/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

https://www.orton.fi

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

Publication citations

Additional files

Editorial Notes

09/01/2020: Trial’s existence confirmed by The Hospital District of Helsinki and Uusimaa Operative Ethics Committee