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

NCT02760589 | Completed

• 1 other identifier: 7/2015
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Anterior Cruciate Ligament Tear

Keywords

ACL tear; ACL lesion; ACL reconstruction; InternalBrace; functional performance test; anterior cruciate ligament

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Limb symmetry Index

  at least one year after Injury / surgery

• Subjective Outcome: German Version of the IKDC Subjective Knee Form (International Knee Documentation Committee

  at least one year after Injury

• Subjective Outcome: German Version of the WOMAC (Western Ontario and McMaster Universities Arthritis Index

  at least one year after Injury

• Subjective Outcome: SF-12 (short form)

  at least one year after Injury

• Subjective Outcome: German Version of the KOOS (Knee Osteoarthritis Outcome Score)

  at least one year after Injury

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with rupture of the ACL between 18 and 60 years

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AUVA: lead

Study Sites (1)

Traumacenter Linz

Linz, Upper Austria, 4010, Austria

Location

Related Publications (15)

• 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.

  PMID: 22695402 BACKGROUND

• Engebretsen L, Benum P, Fasting O, Molster 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. doi: 10.1177/036354659001800605.

  PMID: 2285086 BACKGROUND

• 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. doi: 10.1136/bmj.38784.384109.2F. Epub 2006 Apr 7.

  PMID: 16603564 BACKGROUND

• 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.

  PMID: 24651979 BACKGROUND

• Gustavsson A, Neeter C, Thomee P, Silbernagel KG, Augustsson J, Thomee 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. doi: 10.1007/s00167-006-0045-6. Epub 2006 Mar 9.

  PMID: 16525796 BACKGROUND

• 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.

  PMID: 24427396 BACKGROUND

• 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. doi: 10.1007/s001670050106.

  PMID: 9826806 BACKGROUND

• Thomee 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.

  PMID: 21932078 BACKGROUND

• Augustsson J, Thomee 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. doi: 10.1007/s00167-004-0518-4. Epub 2004 May 8.

  PMID: 15138668 BACKGROUND

• Thomee R, Neeter C, Gustavsson A, Thomee 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.

  PMID: 22314862 BACKGROUND

• Bjorklund K, Andersson L, Dalen 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.

  PMID: 19039577 BACKGROUND

• 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. doi: 10.2522/ptj.20060143. Epub 2007 Feb 20.

  PMID: 17311886 BACKGROUND

• Ageberg E, Thomee 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.

  PMID: 19035430 BACKGROUND

• 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.

  PMID: 26535266 BACKGROUND

• Micheo W, Hernandez 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.

  PMID: 20970763 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Georg Mattiassich, MD

  AUVA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. unit.

Study Record Dates

• First Submitted: November 27, 2015
• First Posted: May 3, 2016
• Study Start: November 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 2, 2018

Record last verified: 2018-06

Locations

AU (1)