Magnetic Resonance Imaging and Functional Performance Outcome After ACL Repair With Internal Brace Technique

June 29, 2018 updated by: Georg Mattiassich, AUVA

Clinical Evaluation After Anterior Cruciate Ligament Tears (Internal Brace Technique vs. ACL Reconstruction vs. Conservative Treatment) With Special Regard to Magnetic Resonance Imaging and Functional Performance

The purpose of the study is a clinical evaluation with special regard to magnetic resonance imaging and functional performance at least one year after injury / surgery in all three groups (subjects who underwent InternalBrace surgery, subjects who underwent surgery with a semitendinosus graft and subjects who were treated conservatively).

Study Overview

Status

Completed

Conditions

Detailed Description

Lesions of the anterior cruciate ligament (ACL) are the most common ligamentous injuries with an increasing incidence. 77% of ACL insufficient knees result in moderate to high physical limitations. Different surgical treatments have been described. ACL reconstruction with either a semitendinosus or patella tendon graft is regarded as the gold standard of operative therapy. Despite numerous studies representing good and excellent outcome after ACL reconstruction, a recent Meta-analysis of Biau et al. 2006 revealed that only 40% of patients gain full functional recovery.

Since the native ACL is considered to be an important factor for the proprioceptive sensation, a removal during the reconstruction might have an adverse influence on muscular stabilisation, rehabilitation and functional performance of the knee joint. Thus a primary repair of the native ACL seems reasonable.

For tears of the anterior cruciate ligament near the femoral attachment a new method of surgical treatment can be applied. The InternalBrace method by Arthrex is performed arthroscopically and involves reattaching of the ACL that has avulsed off the femoral wall using a FiberTape by Arthrex. To the authors knowledge the augmentation with FiberTape by Arthrex has not been systematically evaluated. Promising results have been presented recently using a comparable method, which showed a high patient satisfaction, faster rehabilitation and a high rate of return to pre-injury sports level.

To assess the functional performance, a further aim of the study is to develop a new test battery consisting of strength tests and single-leg hop tests with the ability to distinguish between the functional performance of the injured and the uninjured leg in patients with ACL deficiency. Test batteries consisting of several hop tests has been described in the previous literature indicating a good test-retest reliability measuring lower leg performance. The functional performance is defined using the limb symmetry index in percent between each individuals lower limbs. This study aims to determine the LSI of healthy subjects using the values achieved by the subjects in the control group. A limb symmetry index (LSI) between 85% and 95% is considered sufficient for return to pivoting sports in patients after knee injury.

Study Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Upper Austria
      • Linz, Upper Austria, Austria, 4010
        • Traumacenter Linz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with rupture of the ACL between 18 and 60 years

Description

Inclusion Criteria:

  • Female and male subjects
  • Age between 18 and 60 years
  • Patients who sustained an isolated rupture of the anterior cruciate ligament at least 12 month after injury (for the subjects who received conservative therapy), respectively surgery (for the two groups in which subjects underwent surgery)
  • MRI-confirmed tear of the anterior cruciate ligament near the femoral attachment
  • Surgical treatment of the InternalBrace group must have been performed within the first six weeks after injury
  • Women of reproductive age
  • Confirmed written consent of each subject

Exclusion Criteria:

  • Injury to the other knee
  • Previous knee injuries which required treatment
  • Concomitant injuries such as fractures, articular cartilage lesions reaching subchondral bone, meniscal tears or lesions of the collateral ligaments which required an additional surgical intervention and therefore an extended post-op rehabilitation protocol
  • Pregnant and nursing women
  • Claustrophobia
  • Existing contraindication against performing an MRI scan
  • Taking certain concomitant medication(s) (especially cortisone), or conditions that interfere with a patient's ability to comply with all procedures
  • Circumstances that interfere with the participant's ability to give informed consent (diminished understanding or comprehension, or a language other than German or English spoken

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
ACL tear - conservative
conservative treatment
ACL tear - ACL reconstruction
reconstruction of the ACL with autologous tendons
ACL tear - Internal brace
augmentation of the ruptured ACL with Internal brace
healthy subjects
control group of healthy subjects with no previous injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signal Intensity in Magnetic resonance Imaging
Time Frame: at least one year after injury
The integration of the ligament in magnetic resonance imaging is represented by using values from 1 to 3 (1= continuous ligament; 2= wavy but continuous ligament contour; 3= non-delineated ligament) which are determined by an experienced independent radiologist. Source of the data: axial, coronal, and sagittal scans with proton density-weighted sequences with and without fat saturation by a 1.5-Tesla MRI unit (1.5-Tesla MRI unit, Espree; Siemens AG, Erlangen, Germany).
at least one year after injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Limb symmetry Index
Time Frame: at least one year after Injury / surgery
The functional performance is defined using the LSI in percent between each individual's lower limbs using a diagnostic battery. The test battery consists of a standardized warm-up protocol followed by an isometric strength test (testing the maximum voluntary isometric contraction) of the hamstrings in prone position in 90 degree knee flexion using a portable dynamometer (Mecmesin Advanced Force Gauge, Mecmesin, UK), which is attached to a wall bar with a non-stretchable rope. After that several single-leg jump tests are performed: (1) single-leg hop for distance, (2) single-leg 6m timed hop, (3) single-leg triple crossover hop for distance and (4) side hop test. Finally, a fatigued single-leg hop for distance is conducted following a fatigue protocol consisting of alternating squat lunges to exhaustion for the duration of two minutes. The LSI will be calculated for the best trial in each of the five hop tests and for the overall combination as an average of the hop tests.
at least one year after Injury / surgery
Subjective Outcome: German Version of the IKDC Subjective Knee Form (International Knee Documentation Committee
Time Frame: at least one year after Injury
Source of the data: knee evaluation form Results: continuous data between 0 and 100
at least one year after Injury
Subjective Outcome: German Version of the WOMAC (Western Ontario and McMaster Universities Arthritis Index
Time Frame: at least one year after Injury
Source of the data: 5-point Likert-type of a subjective patient questionnaire of 24 items divided into 3 subscales (pain: 5 items, stiffness: 2 items, physical function: 17 items) Result: ordinal data (pain=0-20, stiffness=0-8, physical function=0-68)
at least one year after Injury
Subjective Outcome: SF-12 (short form)
Time Frame: at least one year after Injury
Source of the data: 5-point Likert-type of a subjective patient questionnaire of 12 items Result: continuous data between 0 and 100 (the higher the number, the better the subjective physical and mental health)
at least one year after Injury
Subjective Outcome: German Version of the KOOS (Knee Osteoarthritis Outcome Score)
Time Frame: at least one year after Injury
Source of the data: patient-administered subjective questionnaire of 5 subscales: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL) What form the data will take: a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
at least one year after Injury
Subjective Outcome: German Version of the modified Lysholm-Score by Lysholm and Gillquist
Time Frame: at least one year after Injury
Source of the data: 8-item patient-administered questionnaire Result: continuous data between 0 and 100
at least one year after Injury
Subjective Outcome: German Version of the TAS (Tegner activity scale)
Time Frame: at least one year after Injury

The physical activity level of all subjects in all groups is estimated with the German Version of the TAS (Tegner activity scale).

Source of the data: patient questionnaire Result: ordinal data between 0 and 10
at least one year after Injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AUVA

Investigators

  • Principal Investigator: Georg Mattiassich, MD, AUVA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 27, 2015

First Submitted That Met QC Criteria

April 30, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

June 29, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Individual data may be allocated confidentially to each individual at the end of the investigation.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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