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

Anterior Cruciate Ligament Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02760589
• Other study ID #: 7/2015
• Status: Completed
• Start date: November 2015
• Est. completion date: December 2017

Study information

• Verified date: June 2018
• Source: AUVA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Tear

Locations

Country	Name	City	State
Austria	Traumacenter Linz	Linz	Upper Austria

Sponsors (1)

Lead Sponsor	Collaborator
AUVA

Country where clinical trial is conducted

Austria, 

References & Publications (15)

Abrams GD, Harris JD, Gupta AK, McCormick FM, Bush-Joseph CA, Verma NN, Cole BJ, Bach BR Jr. Functional Performance Testing After Anterior Cruciate Ligament Reconstruction: A Systematic Review. Orthop J Sports Med. 2014 Jan 21;2(1):2325967113518305. doi: 10.1177/2325967113518305. eCollection 2014 Jan. Review. — View Citation

Ageberg E, Thomeé R, Neeter C, Silbernagel KG, Roos EM. Muscle strength and functional performance in patients with anterior cruciate ligament injury treated with training and surgical reconstruction or training only: a two to five-year followup. Arthritis Rheum. 2008 Dec 15;59(12):1773-9. doi: 10.1002/art.24066. — View Citation

Augustsson J, Thomeé R, Karlsson J. Ability of a new hop test to determine functional deficits after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2004 Sep;12(5):350-6. Epub 2004 May 8. — View Citation

Biau DJ, Tournoux C, Katsahian S, Schranz PJ, Nizard RS. Bone-patellar tendon-bone autografts versus hamstring autografts for reconstruction of anterior cruciate ligament: meta-analysis. BMJ. 2006 Apr 29;332(7548):995-1001. Epub 2006 Apr 7. — View Citation

Björklund K, Andersson L, Dalén N. Validity and responsiveness of the test of athletes with knee injuries: the new criterion based functional performance test instrument. Knee Surg Sports Traumatol Arthrosc. 2009 May;17(5):435-45. doi: 10.1007/s00167-008-0674-z. Epub 2008 Nov 28. — View Citation

Eggli S, Kohlhof H, Zumstein M, Henle P, Hartel M, Evangelopoulos DS, Bonel H, Kohl S. Dynamic intraligamentary stabilization: novel technique for preserving the ruptured ACL. Knee Surg Sports Traumatol Arthrosc. 2015 Apr;23(4):1215-21. doi: 10.1007/s00167-014-2949-x. Epub 2014 Mar 21. — View Citation

Engebretsen L, Benum P, Fasting O, Mølster A, Strand T. A prospective, randomized study of three surgical techniques for treatment of acute ruptures of the anterior cruciate ligament. Am J Sports Med. 1990 Nov-Dec;18(6):585-90. — View Citation

Gustavsson A, Neeter C, Thomeé P, Silbernagel KG, Augustsson J, Thomeé R, Karlsson J. A test battery for evaluating hop performance in patients with an ACL injury and patients who have undergone ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2006 Aug;14(8):778-88. Epub 2006 Mar 9. — View Citation

Itoh H, Kurosaka M, Yoshiya S, Ichihashi N, Mizuno K. Evaluation of functional deficits determined by four different hop tests in patients with anterior cruciate ligament deficiency. Knee Surg Sports Traumatol Arthrosc. 1998;6(4):241-5. — View Citation

Manske R, Reiman M. Functional performance testing for power and return to sports. Sports Health. 2013 May;5(3):244-50. doi: 10.1177/1941738113479925. — View Citation

Micheo W, Hernández L, Seda C. Evaluation, management, rehabilitation, and prevention of anterior cruciate ligament injury: current concepts. PM R. 2010 Oct;2(10):935-44. doi: 10.1016/j.pmrj.2010.06.014. Review. — View Citation

Reid A, Birmingham TB, Stratford PW, Alcock GK, Giffin JR. Hop testing provides a reliable and valid outcome measure during rehabilitation after anterior cruciate ligament reconstruction. Phys Ther. 2007 Mar;87(3):337-49. Epub 2007 Feb 20. — View Citation

Siegel L, Vandenakker-Albanese C, Siegel D. Anterior cruciate ligament injuries: anatomy, physiology, biomechanics, and management. Clin J Sport Med. 2012 Jul;22(4):349-55. doi: 10.1097/JSM.0b013e3182580cd0. Review. — View Citation

Thomeé R, Kaplan Y, Kvist J, Myklebust G, Risberg MA, Theisen D, Tsepis E, Werner S, Wondrasch B, Witvrouw E. Muscle strength and hop performance criteria prior to return to sports after ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2011 Nov;19(11):1798-805. doi: 10.1007/s00167-011-1669-8. Epub 2011 Sep 20. Review. — View Citation

Thomeé R, Neeter C, Gustavsson A, Thomeé P, Augustsson J, Eriksson B, Karlsson J. Variability in leg muscle power and hop performance after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2012 Jun;20(6):1143-51. doi: 10.1007/s00167-012-1912-y. Epub 2012 Feb 8. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Signal Intensity in Magnetic resonance Imaging	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	Limb symmetry Index	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
Secondary	Subjective Outcome: German Version of the IKDC Subjective Knee Form (International Knee Documentation Committee	Source of the data: knee evaluation form Results: continuous data between 0 and 100	at least one year after Injury
Secondary	Subjective Outcome: German Version of the WOMAC (Western Ontario and McMaster Universities Arthritis Index	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
Secondary	Subjective Outcome: SF-12 (short form)	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
Secondary	Subjective Outcome: German Version of the KOOS (Knee Osteoarthritis Outcome Score)	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
Secondary	Subjective Outcome: German Version of the modified Lysholm-Score by Lysholm and Gillquist	Source of the data: 8-item patient-administered questionnaire Result: continuous data between 0 and 100	at least one year after Injury
Secondary	Subjective Outcome: German Version of the TAS (Tegner activity scale)	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