Clinical trial NCT01692756: Early Treatment for Acute ACL Tear
Official title: Early Anti-inflammatory Treatment in Patients With Acute ACL Tear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anterior Cruciate Ligament (ACL) Tears
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Vanderbilt University
First posted: 2012-09-25
Enrollment: 49
Sex: ALL
Minimum age (years): 14
Maximum age (years): 33
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study is the first of its kind and will allow health care professionals and researchers to answer many questions about the reasons why anterior cruciate ligament (ACL) injury leads to knee pain and disability and osteoarthritis. We also hope that this study will be the beginning of new, more powerful and safer drugs to help patients with ACL injuries heal sooner and return to sports or daily activities pain free. Study participants will be recruited from the University of Kentucky and Vanderbilt University.

The purpose of this research is to gather information on how safe and effective Kenalog® is in alleviating knee pain following ACL rupture.

Detailed description: Injury to the knee during sports participation often involves partial of full detachment of the ACL. ACL tears cause pain, swelling and inflammation. While the swelling and inflammation usually goes away in time, individuals with ACL injuries may experience pain and notice knee instability (knee slipping, etc.). Often surgery can repair or replace the ACL within the joint, allowing individuals the ability to walk or run again pain free or participate in sports. Unfortunately, osteoarthritis of the knee, which also causes pain and swelling, can occur in that same knee 10-20 years later for reasons which are not well understood.

In this research study, we hope to prevent and reduce the initial post-operative pain. The reduction of pain will allow for earlier movement of the knee joint and preparation for surgery. It may also reduce the risk to develop osteoarthritis in individuals with ACL injuries by treating them within 1-2 days after their injury.

Eligibility criteria: Inclusion Criteria:

* currently participating in sporting activities
* Normal contralateral knee status
* Anterior Cruciate Ligament (ACL) injury occurred while playing a sporting activity

Exclusion Criteria:

* underlying inflammatory disease (i.e. Rheumatoid Arthritis, Psoriatic Arthritis, etc.)
* have been diagnosed with hepatitis B or tuberculosis
* currently have an infection, including infection of the skin
* have a disease that weakens your immune system such as diabetes, cancer, HIV or AIDs
* other major medical condition requiring treatment with immunosuppressant or modulating drugs.
* A history of chronic use of non-steroidal anti-inflammatory drugs
* previous exposure or allergic reaction to Kenalog
* prior knee surgery (Ipsilateral or contralateral)
* have received any investigational drug with 4 weeks of study Visit 1

Primary outcomes:
measure: Participant Pain Assessment
timeFrame: Up to seven days
Secondary outcomes:
measure: Efficacy of Kenalog to Alleviate Knee Pain
timeFrame: Up to seven days
measure: Synovial Interleukin-1α (IL-1α) Concentration
timeFrame: Up to seven days
measure: Synovial Interleukin-1β (IL-1β) Concentration
timeFrame: Up to seven days
measure: Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration
timeFrame: Up to seven days
measure: Synovial C-terminal Peptide II (CTXII) Concentration
timeFrame: Up to seven days
measure: Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration
timeFrame: Up to seven days
measure: Synovial Glycosaminoglycans (GAG) Concentration
timeFrame: Up to seven days
measure: Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration
timeFrame: Up to seven days
measure: Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration
timeFrame: Up to seven days
measure: Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration
timeFrame: Up to seven days
measure: Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration
timeFrame: Up to seven days
measure: Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration
timeFrame: Up to seven days
Other outcomes:
Locations:
city: Lexington
country: United States
facility: UK HeathCare Sports Medicine
state: Kentucky
Study officials:
affiliation: University of Kentucky, Department of Orthopaedic Surgery
name: Christian Lattermann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lattermann C, Jacobs CA, Proffitt Bunnell M, Huston LJ, Gammon LG, Johnson DL, Reinke EK, Huebner JL, Kraus VB, Spindler KP. A Multicenter Study of Early Anti-inflammatory Treatment in Patients With Acute Anterior Cruciate Ligament Tear. Am J Sports Med. 2017 Feb;45(2):325-333. doi: 10.1177/0363546516666818. Epub 2016 Oct 7.
citation: Lattermann C, Jacobs CA, Bunnell MP, Jochimsen KN, Abt JP, Reinke EK, Gammon LG, Huebner JL, Kraus VB, Spindler KP. Logistical challenges and design considerations for studies using acute anterior cruciate ligament injury as a potential model for early posttraumatic osteoarthritis. J Orthop Res. 2017 Mar;35(3):641-650. doi: 10.1002/jor.23329. Epub 2016 Jun 30.
citation: King JD, Rowland G, Villasante Tezanos AG, Warwick J, Kraus VB, Lattermann C, Jacobs CA. Joint Fluid Proteome after Anterior Cruciate Ligament Rupture Reflects an Acute Posttraumatic Inflammatory and Chondrodegenerative State. Cartilage. 2020 Jul;11(3):329-337. doi: 10.1177/1947603518790009. Epub 2018 Jul 22.