Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Montelukast | Study protocol

MOntelukast as a potential CHondroprotective treatment following Anterior cruciate ligament reconstruction (MOCHA Trial): study protocol for a double-blind, randomized, placebo-controlled clinical trial

Authors: Cale A. Jacobs, Caitlin E. W. Conley, Virginia Byers Kraus, Drew A. Lansdown, Brian C. Lau, Xiaojuan Li, Sharmila Majumdar, Kurt P. Spindler, Nicole G. Lemaster, Austin V. Stone

Published in: Trials | Issue 1/2022

Login to get access

Abstract

Background

After anterior cruciate ligament (ACL) reconstruction, patient-reported outcomes are improved 10 years post-surgery; however, cytokine concentrations remain elevated years after surgery with over 80% of those with combined ACL and meniscus injuries having posttraumatic osteoarthritis (PTOA) within 10–15 years. The purpose of this multicenter, randomized, placebo-controlled trial is to assess whether a 6-month course of oral montelukast after ACL reconstruction reduces systemic markers of inflammation and biochemical and imaging biomarkers of cartilage degradation.

Methods

We will enroll 30 individuals undergoing primary ACL reconstruction to participate in this IRB-approved multicenter clinical trial. This trial will target those at greatest risk of a more rapid PTOA onset (age range 25–50 with concomitant meniscus injury). Patients will be randomly assigned to a group instructed to take 10 mg of montelukast daily for 6 months following ACL reconstruction or placebo. Patients will be assessed prior to surgery and 1, 6, and 12 months following surgery. To determine if montelukast alters systemic inflammation following surgery, we will compare systemic concentrations of prostaglandin E2, monocyte chemoattractant protein-1, and pro-inflammatory cytokines between groups. We will also compare degradative changes on magnetic resonance imaging (MRI) collected 1 and 12 months following surgery between groups with reductions in early biomarkers of cartilage degradation assessed with urinary biomarkers of type II collagen breakdown and bony remodeling.

Discussion

There is a complex interplay between the pro-inflammatory intra-articular environment, underlying bone remodeling, and progressive cartilage degradation. PTOA affects multiple tissues and appears to be more similar to rheumatoid arthritis than osteoarthritis with respect to inflammation. There is currently no treatment to delay or prevent PTOA after ACL injury. Since there is a larger and more persistent inflammatory response after ACL reconstruction than the initial insult of injury, treatment may need to be initiated after surgery, sustained over a period of time, and target multiple mechanisms in order to successfully alter the disease process. This study will assess whether a 6-month postoperative course of oral montelukast affects multiple PTOA mechanisms. Because montelukast administration can be safely sustained for long durations and offers a low-cost treatment option, should it be proven effective in the current trial, these results can be immediately incorporated into clinical practice.

Trial registration

ClinicalTrials.​govNCT04572256. Registered on October 1, 2020.
Appendix
Available only for authorised users
Literature
1.
Spindler KP, Huston LJ, Chagin KM, Kattan MW, Reinke EK, Amendola A, et al. Ten-year outcomes and risk factors after anterior cruciate ligament reconstruction: a MOON longitudinal prospective cohort study. Am J Sports Med. 2018;46(4):815–25.PubMed
2.
Larsson S, Struglics A, Lohmander LS, Frobell R. Surgical reconstruction of ruptured anterior cruciate ligament prolongs trauma-induced increase of inflammatory cytokines in synovial fluid: an exploratory analysis in the KANON trial. Osteoarthritis Cartilage. 2017;25(9):1443–51.PubMed
3.
Oiestad BE, Holm I, Engebretsen L, Risberg MA. The association between radiographic knee osteoarthritis and knee symptoms, function and quality of life 10-15 years after anterior cruciate ligament reconstruction. Br J Sports Med. 2011;45(7):583–8.PubMed
4.
Lattermann C, Jacobs CA, Proffitt Bunnell M, Huston LJ, Gammon LG, Johnson DL, et al. A multicenter study of early anti-inflammatory treatment in patients with acute ACL tear. Am J Sports Med. 2017;45(2):325–33.PubMed
5.
Rivera JD, Wenke JC, Buckwalter JA, Ficke JR, Johnson AE. Posttraumatic osteoarthritis caused by battlefield injuries: the primary source of disability in warriors. J Am Acad Orthop Surg. 2012;20(1):S64–S9.PubMedPubMedCentral
6.
Showery JE, Kusnezov NA, Dunn JC, Bader JO, Belmont PJ Jr, Waterman BR. The rising incidence of degenerative and posttraumatic osteoarthritis of the knee in the United States military. J Arthroplasty. 2016;31(10):2108–14.PubMed
7.
Brown TD, Johnston RC, Saltzman CL, Marsh JL, Buckwalter JA. Posttraumatic osteoarthritis: a first estimate of incidence, prevalence, and burden of disease. J Orthop Trauma. 2006;20(10):739–44.PubMed
8.
Thomas AC, Hubbard-Turner T, Wikstrom EA, Palmieri-Smith RM. Epidemiology of posttraumatic osteoarthritis. J Athl Train. 2017;52(6):491–6.PubMedPubMedCentral
9.
Lattermann C, Jacobs CA, Proffitt Bunnell M, Jochimsen KN, Abt JP, Reinke EK, et al. Logistical challenges and design considerations for studies using acute anterior cruciate ligament injury as a potential model for early posttraumatic arthritis. J Orthop Res. 2017;35(5):641–50.PubMed
10.
Stone AV, Loeser RF, Vanderman KS, Long DL, Clark SC, Ferguson CM. Pro-inflammatory stimulation of meniscus cells increases production of matrix metalloproteinases and additional catabolic factors involved in osteoarthritis pathogenesis. Osteoarthritis Cartilage. 2014;22(2):264–74.PubMed
11.
Stone AV, Vanderman KS, Willey JS, Long DL, Register TC, Shively CA, et al. Osteoarthritic changes in vervet monkey knees correlate with meniscus degeneration and increased matrix metalloproteinase and cytokine secretion. Osteoarthritis Cartilage. 2015;23(10):1780–9.PubMedPubMedCentral
12.
Jacobs CA, Hunt ER, Conley CE, Johnson DL, Stone AV, Huebner JL, et al. Dysregulated inflammatory response related to cartilage degradation after ACL injury. Med Sci Sports Exerc. 2020;52(3):535–41.PubMedPubMedCentral
13.
King JD, Rowland G, Villasante Tezanos AG, Warwick J, Kraus VB, Lattermann C, et al. Joint fluid proteome after anterior cruciate ligament rupture reflects an acute inflammatory and chondrodegenerative state. Cartilage. 2020;11(3):329–37.PubMed
14.
Lattermann C, Conley CE-W, Johnson DJ, Reinke EK, Huston LJ, Huebner JL, et al. Select biomarkers on the day of anterior cruciate ligament reconstruction predict poor patient-reported outcomes at 2-year follow-up: a pilot study. BioMed Research International. 2018;2018:9387809.PubMedPubMedCentral
15.
Hunt ER, Jacobs CA, Conley CE-W, Ireland ML, Johnson DJ, Lattermann C. Anterior cruciate ligament reconstruction reinitiates an inflammatory and chondrodegenerative process in the knee joint. J Orthop Res. 2020;Epub ahead of print: https://​doi.​org/​10.​1002/​jor.​24783.
16.
17.
18.
Berenbaum F. Osteoarthritis as an inflammatory disease (osteoarthritis is not osteoarthrosis!). Osteoarthritis Cartilage. 2013;21:16–21.PubMed
19.
Potter HG, Jain SK, Ma Y, Black BR, Fung S, Lyman S. Cartilage injury after acute, isolated anterior cruciate ligament tear: immediate and longitudinal effect with clinical/MRI follow-up. Am J Sports Med. 2012;40:276–85.PubMed
20.
Kroker A, Besler BA, Bhatla JL, Shtil M, Salat P, Mohtadi N, et al. Longitudinal effects of acute anterior cruciate ligament tears on peri-articular bone in human knees within the first year of injury. J Orhtop Res. 2019;37:2325–36.
21.
22.
Watt FE, Gulati M. New drug treatments for osteoarthritis: what is on the horizon? Eur Med J Rheumatol. 2017;2(1):50–8.PubMedPubMedCentral
23.
24.
Song W, Zhan Y, Wang J, Ma T, Hao L, Wang K. Antagonism of cysteinyl leukotriene receptor 1 (cysLTR1) by montelukast suppresses cell senescence of chondrocytes. Cytokine. 2018;103:83–9.PubMed
25.
Jeon OH, Kim C, Laberge R-M, Demaria M, Rathod S, Vasserot AP, et al. Local clearance of senescent cells attenuates the development of post-traumatic osteoarthritis and creates a pro-regenerative environment. Nature Medicine. 2017;23(6):775–83.PubMedPubMedCentral
26.
Lei C, Wu S, Wen C, Li Y, Liu N, Huang J, et al. Zafirlukast attenuates advances glycation end-products (AGEs)-induced degradation of articular extracellular matrix (ECM). Int Immunopharmacology. 2019;68:68–73.
27.
Venugopal N, Acharya P, Zarei M, Talahalli RR. Cysteinyl leukotriene receptor antagonism: a promising pharmacological strategy for lowering the severity of arthritis. Inflammopharmacology. 2019;27:923–31.PubMed
28.
Wixted JJ, Fanning PJ, Gaur T, O’Connell SL, Silva J, Mason-Savas A, et al. Enhanced fracture repair by leukotriene antagonism is characterized by increased chondrocyte proliferation and early bone formation: a novel role of the cysteinyl LT-1 receptor. J Cell Physiol. 2009;222(1):31–9.
29.
Kang J-H, Lim H, Lee D-S, Yim M. Montelukast inhibits RANKL-induced osteoclast formation and bone loss via CysLTR1 and P2Y12. Molecular Med Reports. 2018;18:2387–98.
30.
31.
Aldea Perona A, Garcia-Saiz M, Sanz AE. Psychiatric disorders and montelukast in children: a disproportionality analysis of the VigiBase(R). Drug Saf. 2016;39(1):69–78.PubMed
32.
Haarman MG, van Hunsel F, de Vries TW. Adverse drug reactions of montelukast in children and adults. Pharma Res Per. 2017;5(5):e00341.
33.
Jones MH, Spindler KP. Risk factors for radiographic joint space narrowing and patient reported outcomes of post-traumatic osteoarthritis after ACL reconstruction: data from the MOON cohort. J Orthop Res. 2017;35(7):1366–74.PubMedPubMedCentral
34.
Jones MH, Spindler KP, Fleming BC, Duryea J, Obuchowski NA, Scaramuzza EA, et al. Meniscus treatment and age associated with narrower radiographic joint space width 2-3 years after ACL reconstruction: data from the MOON onsite cohort. Osteoarthritis Cartilage. 2015;23(4):581–8.PubMedPubMedCentral
35.
MARS Group, Magnussen RA, Borchers JR, Pedroza AD, Huston LJ, Haas AK, et al. Risk factors and predictors of significant chondral surface change from primary to revision anterior cruciate ligament reconstruction. A MOON and MARS cohort study. Am J Sports Med. 2018;46(3):557–64.
36.
Dunn WR, Spindler KP, Amendola A, Andrish JT, Kaeding CC, Marx RG, et al. Which preoperative factors, including bone bruise, are associated with knee pain / symptoms at index anterior cruciate ligament reconstruction (ACLR)? A Multicenter Orthopaedic Outcomes Network (MOON) ACLR Cohort Study. Am J Sports Med. 2010;38(9):1778–87.PubMedPubMedCentral
37.
Lattermann C, Jacobs CA, Reinke EK, Scaramuzza EA, Huston LJ, Dunn WR, et al. Are bone bruise characteristics and articular cartilage pathology associated with inferior outcomes two and six years after anterior cruciate ligament reconstruction? Cartilage. 2017;8(2):139–45.PubMed
38.
Gong J, Pedoia V, Facchetti L, Link TM, Ma CB, Li X. Bone marrow edema-like lesions (BMELs) are associated with higher T1rho and T2 values in cartilage in anterior cruciate ligament (ACL)-reconstructed knees: a longitudinal study. Quant Imaging Med Surg. 2016;6(6):661–70.PubMedPubMedCentral
39.
Baumann NP, Johnson AK, Heebner NR, Conley CE-W, Jacobs CA, Johnson DL, et al. Hyaluronate injections after anterior cruciate ligament reconstruction does not improve running mechanics. Med Sci Sports Exerc. 2019;51(6 Suppl):263.
40.
Cook AE, Stoker AM, Leary EV, Pfeiffer FM, Cook JL. Metabolic responses of meniscal explants to injury and inflammation ex vivo. J Orthop Res. 2018;36:2657–63.PubMed
41.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.PubMedPubMedCentral
42.
Chen S-H, Fahmi H, Shi Q, Benderdour M. Regulation of microsomal prostaglandin E2 synthase-1 and 5-lipoxygenase-activating protein/5-lipoxygenase by 4-hydroxynonenal in human osteoarthritic chondrocytes. Arthritis Res Ther. 2010;12:R21.PubMedPubMedCentral
43.
Martel-Pelletier J, Lajeunesse D, Reboul P, Pelletier JP. Therapeutic role of dual inhibitors of 5-LOX and COX, selective and non-selective non-steroidal anti-inflammatory drugs. Ann Rheum Dis. 2003;62:501–9.PubMedPubMedCentral
44.
Allen-Ramey FC, Anstatt DT, Riedel AA, Markson LE. Greater adherence in montelukast patients compared to those on fluticasone. J Allergy Clin Immunol. 2004;113(2 Suppl):S158.
45.
Dong H, Liu F, Ma F, Xu L, Pang L, Li X, et al. Montelukast inhibits inflammatory response in rheumatoid arthritis fibroblast-like synoviocytes. Int Immunopharmacology. 2018;61:215–21.
46.
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16:606–13.PubMedPubMedCentral
47.
Arroll B, Goodyear-Smith F, Crengle S, Gunn J, Kerse N, Fishman T, et al. Validation of PHQ-2 and PHQ-9 to screen for major depression in the primary care population. Ann Fam Med. 2010;8(4):348–53.PubMedPubMedCentral
48.
Canbay E, Agachan B, Ozturk T, Giris M, Asoglu O, Balik E, et al. Dual inhibition of wound healing and oxidative process by montelukast in experimental colon anastomoses. Surg Innovation. 2010;17(3):248–55.
49.
Polat A, Kerem Canbora M, Akakin D, Aykanat F. Effects of montelukast sodium on tendon healing: an experimental study. Indian J Orthop. 2013;47(5):500–4.PubMedPubMedCentral
50.
Tolazzi AR, Tolazzi KD, Garcia M, Graf RM, Freitas RS, Baretta GA, et al. Influence of leukotriene inhibitor montelukast on wound contraction and cutaneous healing process in rats. Aesthetic Plastic Surgery. 2008;33(1):84–9.PubMed
51.
Celik A, Ergun E, Koksal N, Simsek Celik A, Altinli E, Ali Uzun M, et al. Effects of montelukast on the healing of ischemic colon anastomoses. Am J Surg. 2013;206:502–8.PubMed
52.
Turtay MG, Firat C, Samdanci E, Oguzturk H, Erbatur S, Colak C. Effects of montelukast on burn wound healing in a rat model. Clin Invest Med. 2010;33(6):E413–E21.PubMed
53.
Kaetsu Y, Yamamoto Y, Sugihara S, Matsuura T, Igawa G, Matsubara K, et al. Role of cysteinyl leukotrienes in the proliferation and the migration of murine vascular smooth muscle cells in vivo and in vitro. Cardiovasc Res. 2007;76(1):160–6.PubMed
54.
Peng J, Zhou H, Kuang G, Xie L, Tian T, Liu R. The selective cysteinyl leukotriene receptor 1 (CysLT1R) antagonist montelukast regulates extracellular matrix remodeling. Biochem Biophys Res Comm. 2017;484:474–9.PubMed
55.
Snijders GF, van den Ende CH, van Riel PL, van den Hoogen FH, den Broeder AA, group Ns. The effects of doxycycline on reducing symptoms in knee osteoarthritis: results from a triple-blinded randomised controlled trial. Ann Rheum Dis. 2011;70(7):1191–6.PubMed
56.
Chu CR, Williams AA. Quantitative MRI UTE-T2* and T2* show progressive and continued graft maturation over 2 years in human patients after anterior cruciate ligament reconstruction. Orthop. J Sports Med. 2019;7:2325967119863056.
57.
Hunter DJ, Guermazi A, Lo GH, Grainger AJ, Conaghan PG, Boudreau RM, et al. Evaluation of semiquantitative whole joint assessment of knee OA: MOAKS (MRI Osteoarthritis Knee Score). Osteoarthritis Cartilage. 2011;19(8):990–1002.PubMedPubMedCentral
58.
Bowes MA, Lohmander LS, Wolstenholme CBH, Vincent GR, Conaghan PG, Frobell RB. Marked and rapid change of bone shape in acutely ACL injured knees - an exploratory analysis of the Kanon trial. Osteoarthritis Cartilage. 2019;27(4):638–45.PubMed
59.
Zhong Q, Pedoia V, Tanaka M, Neumann J, Link TM, Ma B, et al. 3D bone-shape changes and their correlations with cartilage T1rho and T2 relaxation times and patient-reported outcomes over 3-years after ACL reconstruction. Osteoarthritis Cartilage. 2019;27:915–21.PubMedPubMedCentral
60.
Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orhtop Sports Phys Ther. 1998;28(2):88–96.
61.
Jacobs CA, Peabody MR, Lattermann C, Vega JF, Huston LJ, Spindler KP, et al. Development of the KOOSglobal platform to measure patient-reported outcomes after anterior cruciate ligament reconstruction. Am J Sports Med. 2018;48(12):2915–21.
62.
Muller B, Yabroudi MA, Lynch A, Lai C-L, van Dijk CN, Fu FH, et al. Defining thresholds for the patient acceptable symptom state for the IKDC subjective knee form and KOOS for patients who underwent ACL reconstruction. Am J Sports Med. 2016;44(11):2820–6.PubMed
63.
Vega JF, Jacobs CA, Strand GJ, Farrow L, Jones MH, Miniaci A, et al. Prospective evaluation of the patient acceptable symptom state to identify clinically successful anterior cruciate ligament reconstruction. Am J Sports Med. 2019;47(5):1159–67.PubMed
64.
Kraus VB, Collins JE, Hargrove D, Losina E, Nevitt M, Katz JN, et al. Predictive validity of biochemical biomarkers in knee osteoarthritis: data from the FNIH OA Biomarkers Consortium. Ann Rheum Dis. 2017;76(1):186–95.PubMed
65.
Kraus VB, Stabler TV, Kong J, Varju G, McDaniel G. Measurement of synovial fluid volume using urea. Osteoarthritis Cartilage. 2007;15(10):1217–20.PubMedPubMedCentral
66.
Amano K, Huebner JL, Stabler TV, Tanaka M, McCulloch CE, Lobach I, et al. Synovial fluid profile at the time of anterior cruciate ligament reconstruction and its association with cartilage matrix composition 3 years after surgery. Am J Sports Med. 2018;46(4):890–9.PubMedPubMedCentral
67.
Liu B, Goode AP, Carter TE, Utturkar GM, Huebner JL, Taylor DC, et al. Matrix metalloproteinase activity and prostaglandin E2 are elevated in the synovial fluid of meniscus tear patients. Connect Tissue Res. 2017;58(3-4):305–16.PubMed
68.
Stabler TV, Montell E, Verges J, Huebner JL, Kraus VB. Chondroitin sulfate inhibits monocyte chemoattractant protein-1 release from 3R3-L1 adipocytes: a new treatment opportunity for obesity-related inflammation? Biomarker Insights. 2017;12:1–4.
69.
Catterall JB, Stabler TV, Flannery CR, Kraus VB. Changes in serum and synovial fluid biomarkers after acute injury (NCT00332254). Arthritis Res Ther. 2010;12(6):R229.PubMedPubMedCentral
70.
Nepple JJ, Thomason KM, An TW, Harris-Hayes M, Clohisy JC. What is the utility of biomarkers for assessing the pathophysiology of hip osteoarthritis? A systematic review. Clin Orthop Related Res. 2015;473:1683–701.
71.
72.
Hunt MA, Pollock CL, Kraus VB, Saxne T, Peters S, Huebner JL, et al. Relationships amongst osteoarthritis biomarkers, dynamic knee joint load, and exercise: results from a randomized controlled pilot study. BMC Musculoskelet Disord. 2013;14:115.PubMedPubMedCentral
73.
Huebner JL, Bay-Jensen AC, Huffman KM, He Y, Leeming DJ, McDaniel GE, et al. ALPHA-CTX is associated with subchondral bone turnover and predicts progression of joint space narrowing and osteophytes in osteoarthritis. Arthritis Rheum. 2014;66(9):2440–9.
74.
Li X, Pedoia V, Kumar D, Rivoire J, Wyatt C, Lansdown D, et al. Cartilage T1rho and T2 relaxation times: longitudinal reproducibility and variations using different coils. MR systems and sites. Osteoarthritis Cartilage. 2015;23(12):2214–23.PubMed
75.
Kim J, Mamoto K, Lartey R, Xu K, Tanaka M, Bahroos E, et al., editors. Multi-vendor multi-site T1ρ and T2 quantification of knee cartilage. Annual Conference of International Society of Magnetic Resonance in Medicine (ISMRM); 2019 May 13-16, 2019; Montreal, Canada.
76.
Li X, Han E, Busse R, Majumdar S. In vivo T1rho mapping in cartilage using 3D magnetization-prepared angle-modulated partitioned k-space spoiled gradient echo snapshots (3D MAPSS). Magn Reson Med. 2008;59(2):298–307.PubMedPubMedCentral
77.
Kraus VB, Hargrove DE, Hunter DJ, Renner JB, Jordan JM. Establishment of reference intervals for osteoarthritis-related soluble biomarkers: the FNIH/OARSI OA Biomarkers Consortium. Ann Rheum Dis. 2017;76(1):179–85.PubMed
78.
Theologis AA, Haughom B, Liang F, Zhang Y, Majumdar S, Link TM, et al. Comparison of T1rho relaxation times between ACL-reconstructed knees and contralateral knees. Knee Surg Sports Traumatol Arthrosc. 2014;22:298–307.PubMed
79.
Samuelsson K, Magnussen RA, Alentorn-Geli E, Krupic F, Spindler KP, Johansson C, et al. Equivalent Knee Injury and Osteoarthritis Outcome Scores 12 and 24 months after anterior cruciate ligament reconstruction: results from the Swedish National Knee Ligament Register. Am J Sports Med. 2017;45(9):2085–91.PubMed
80.
Feucht MJ, Cotic M, Saier T, Minzlaff P, Plath JE, Imhoff AB, et al. Patient expectations of primary and revision anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2016;24:201–7.PubMed
81.
Jin J, Sklar GE, Oh VMS, Li SC. Factors affecting therapeutic compliance: a review from the patient’s perspective. Ther Clin Risk Manage. 2008;4(1):269–86.
82.
Kelloway JS, Wyatt RS, Adlis SA. Comparison of patients’ compliance with prescribed oral and inhaled asthma medications. Arch Intern Med. 1994;154:1349–52.PubMed
83.
Nichols-English G, Poirier S. Optimizing adherence to pharmaceutical care plans. J Am Pharm Assoc. 2000;40:475–85.
84.
Wright RW, Haas AK, Anderson J, Calabrese G, Cavanaugh J, Hewett TE, et al. Anterior cruciate ligament reconstruction rehabilitation: MOON guidelines. Sports Health. 2015;7(3):239–43.PubMedPubMedCentral
Metadata
Title
MOntelukast as a potential CHondroprotective treatment following Anterior cruciate ligament reconstruction (MOCHA Trial): study protocol for a double-blind, randomized, placebo-controlled clinical trial
Authors
Cale A. Jacobs
Caitlin E. W. Conley
Virginia Byers Kraus
Drew A. Lansdown
Brian C. Lau
Xiaojuan Li
Sharmila Majumdar
Kurt P. Spindler
Nicole G. Lemaster
Austin V. Stone
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-021-05982-3

Other articles of this Issue 1/2022

Trials 1/2022 Go to the issue

Study protocol

Rifapentine and isoniazid for prevention of tuberculosis in people with diabetes (PROTID): protocol for a randomised controlled trial

Study protocol

The Unplugged program in Chile (“Yo Sé Lo Que Quiero”) for substance use prevention among early adolescents: study protocol for a randomized controlled trial

Study protocol

Effectiveness and cost-effectiveness of sector-independent treatment coordination for people with substance-related disorders following an online assessment (ASSIST): study protocol for a randomized controlled trial

Study protocol

The effect of “moderately restricted carbohydrate” diet on gut microbiota composition and metabolic parameters in women with metabolic syndrome: a study protocol for a randomized controlled trial

Research

The effects of remifentanil-propofol combined with dexmedetomidine on cognitive dysfunction in elderly patients after ureteroscopic holmium laser lithotripsy: a double-blind randomized controlled trial

Study protocol

A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design