Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06171555 |
| Other study ID # |
IHTSC CTM Project HC22-1 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
January 26, 2023 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
December 2023 |
| Source |
Indiana Hand to Shoulder Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this study, the objective is to evaluate the effectiveness of a single application of
human Connective Tissue Allograft (CTA) as a treatment of LET. CTM Biomedical markets and
distributes decellularized particulate human placental connective-tissue matrix products,
intended solely for homologous use to supplement or replace damaged or inadequate
connective-tissue. These are structural tissue allografts processed according to the criteria
contained in 21CFR 1271.10(a) for regulation solely under section 361 of the Public Health
Service Act. Drug/Device Handling: If the research involves drugs or device, describe your
plans to store, handle, and administer those drugs or devices so that they will be used only
on subjects and be used only by authorized investigators.
Description:
Lateral Elbow Tendinopathy (LET) is considered an overload injury of the extensor tendons of
the forearm where they attach at the lateral epicondyle. LET is a common condition
encountered both in primary care and specialty clinics. A population-based study reported an
incidence of 3.4 (95% CI, 3.3-3.5) per 1000. The highest incidence was among individuals aged
40 to 49 years, with 7.8 per 1000 in male patients and 10.2 per 1000 in female patients. Work
restrictions were reported in 16% of the patients, and 4% reported missing 1 to 12 weeks of
work. The recurrence rate within 2 years was 8.5% and remained constant over time. The study
data suggest that patients without resolution after 6 months of onset may have a prolonged
disease course and may need surgical intervention. The patient demographic is typically
active in the workforce and LET related absenteeism results in a substantial economic impact.
Pain relief, timely return to work, and avoidance of surgical intervention are therefore
important LET treatment goals. Patients suffering from LET are grouped into 2 entities: Group
1 experience symptoms in an acute (tendinitis) phase that is largely influenced by the local
inflammation stemming from over-use activities. Group 2 developed tendon degeneration and/or
bony responses due to a persistent, chronic (tendinosis) pathology. Histologic specimens from
chronic cases confirm that tendinosis is not an acute inflammatory condition but rather a
failure of the normal tendon repair mechanism associated with angio-fibroblastic
degeneration. The cause of elbow tendinosis is most likely a combination of mechanical
overloading and abnormal microvascular responses. Further research into the precise cause of
tendinosis is, however, still needed. The chief complaint in both groups is elbow pain with
or without activity. Numerous methods have been advocated for treating LET including rest,
nonsteroidal anti-inflammatory medication, bracing, physical therapy, iontophoresis,
extracorporeal shock wave therapy, and botulism toxin. Injections of corticosteroids or whole
blood, and various types of surgical procedures have also been recommended. The utility of
several of these treatments has recently come into question. For example, one recent report
noted that there is no difference between using corticosteroid or local anesthetic when
treating elbow tendinosis with an injection. A recent review of common growth factors
suggested human CTA may be useful for tendon and ligament healing in vivo.
The primary study endpoint is based on the hypothesis that treatment of LET with a single
application of CTA will provide a clinically meaningful improvement of the Patient-Related
Tennis Elbow Evaluation (PRTEE) Pain Subscale Secondary endpoints include VAS pain and elbow
range of motion. Secondary endpoints also include PROMIS scores of pain interference and
depression. A single assessment numerical evaluation (SANE) of elbow function will also be
obtained.
