Phase 2
N=49
Early Treatment for Acute ACL Tear
Anterior Cruciate Ligament (ACL) Tears
Bottom Line
View on ClinicalTrials.gov: NCT01692756 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Participant Pain Assessment — -3.9; -2.2; -3.6; -4.3 units on a scale — p=0.33
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Kenalog or placebo (Drug); Kenalog then Placebo (Drug); Kenalog (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- All
- Sponsor
- Cale Jacobs
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Pain Assessment |
-3.9; -2.2; -3.6; -4.3 | 0.33 |
| SECONDARY Efficacy of Kenalog to Alleviate Knee Pain |
37.37; 18.94; 30.56; 28.93 | 0.08 |
| SECONDARY Synovial Interleukin-1α (IL-1α) Concentration |
4.30; 7.68; 1.77; 3.11 | 0.93 |
| SECONDARY Synovial Interleukin-1β (IL-1β) Concentration |
-1.08; 0.75; -0.28; -0.19 | 0.13 |
| SECONDARY Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration |
-3352.5; -4955.6; -7278.4; -6888.5 | 0.15 |
| SECONDARY Synovial C-terminal Peptide II (CTXII) Concentration |
0.32; 0.23; 0.19; 1.32 | .003 sig |
| SECONDARY Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration |
-4.9; -21.7; -11.7; -22.1 | .007 sig |
| SECONDARY Synovial Glycosaminoglycans (GAG) Concentration |
-73.1; 155.8; -49.0; -167.4 | .63 |
| SECONDARY Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration |
3.5; 0.6; 2.6; 5.8 | 0.17 |
| SECONDARY Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration |
68.0; 57.6; 111.4; -4.9 | .62 |
| SECONDARY Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration |
249.0; -183.0; -395.5; -100.4 | .02 sig |
| SECONDARY Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration |
2702.9; 504.0; -512.4; 1295.9 | .20 |
| SECONDARY Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration |
-71.1; -28.9; -17.7; -14.0 | .87 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01692756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.