Clinical trial NCT06171529: Efficacy of a Single Injection of CTM for Post-Operative CMC Arthritis
Official title: Efficacy of a Single Injection of Connective Tissue Matrix for Post-Operative CMC Arthritis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Osteoarthritis
Osteoarthritis Thumb Base Joint
Carpometacarpal Osteoarthritis
Thumb
Lead sponsor: Indiana Hand to Shoulder Center
Sponsor class: OTHER
Collaborators: name: CTM Biomedical
First posted: 2023-12-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: For patients who randomize to CTM: An unblinded IHTSC Fellow, nurse/PA, or OR staff will use a 3 or 5 cc syringe to draw up the CTM Flow material. A 23, or 20 gauge needle will be used to inject the CTM after arthroplasty and prior to closure of the capsule. To draw up the injection: allow the particulate to settle to the bottom and withdrawal fluid into the 3 or 5 cc syringe. It is ok if some particulate is drawn up into the syringe. 2cc of CTM will be injected into each patient.

For patients who randomize to Saline: An unblinded IHTSC Fellow, nurse/PA, or OR staff will use a 3 or 5 cc syringe to draw up the saline. A 23 gauge needle will be used to inject the saline after arthroplasty and prior to closure of the capsule. 2cc of saline will be injected into each patient.
Primary purpose: TREATMENT

Brief summary: The goal of this study is to determine the success rate of a single Carpometacarpal (CMC) thumb injection after arthroplasty surgery for primary osteoarthritis of the CMC joint.

Detailed description: 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. CTM Flow is decellularized particulate human placental connective-tissue matrix provided in a vial.

Postoperative pain after basilar thumb arthritis reconstruction is often quite significant. CTM flow is an extracellular matrix implant that supplements and replaces damaged tissues. Small unpublished case series in total knee arthroplasty, ENT procedures, and rotator cuff repair have shown beneficial results from CTM. We hope to show similar results in this assessment of CTM in the Post-operative CMC arthroplasty patient population.

The primary outcome measure will be narcotic use postoperatively in the first 3 weeks after surgery, as measured by patient tracking. Patients will track post-op pain meds including narcotics, and OTC pain medication for the duration of their follow up period. Per standard of care, patients will be encouraged to change to Tylenol and/or ibuprofen pain medicine as soon as they are able.

Secondary outcomes will be quickDASH and VAS pain.

Eligibility criteria: Inclusion Criteria:

1. Males or females age 18 or older
2. Patients presenting for basilar thumb reconstruction surgery (any surgical technique)
3. Patients who can consent to be a part of this study
4. Patients who are able to return to the Indiana Hand to Shoulder Center or satellite location for follow up time points

Exclusion Criteria:

1. Additional procedures at the same time
2. Patients with previous basilar thumb reconstruction on the operative side (revision surgery)
3. Chronic narcotic use
4. Women who are pregnancy or breastfeeding
5. Non-English speaking

Primary outcomes:
measure: Narcotic Use
timeFrame: 6 Weeks
Secondary outcomes:
measure: VAS Pain
timeFrame: 6 Months
measure: quickDASH
timeFrame: 6 Months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana Hand to Shoulder Center
state: Indiana
Study officials:
References: