Ankle Arthritis, Ankle Arthropathy
Conditions
Brief summary
Ankle arthritis is associated with debilitating pain and chronic disability. For the treatment of severe ankle arthritis, total ankle arthroplasty (TAA) is one treatment option. Postoperative pain management in joint arthroplasty is an ongoing and relevant issue. The purpose of this study is to examine if differences exist in postoperative pain control, overall patient satisfaction, and use of narcotics using an intra-articular injection in the operating room compared with a peripheral nerve block in patients undergoing TAA.
Detailed description
This is a two-arm, prospective, randomized, controlled clinical study. Use of intra-articular injections in TAA are not widely reported in literature; however, they are commonly used during total knee arthroplasty's (TKAs). The purpose of this study is to examine if differences exist in postoperative pain control, overall patient satisfaction, and use of narcotics using the intra-articular injection compared with a peripheral nerve block in patients undergoing TAA. Results will contribute to the literature for the best surgical practice for pain management following a TAA for ankle arthritis. Patients will be randomized to receive one of the following interventions for pain control in the operating room: 1. Intra-articular Injection 2. Preoperative Peripheral Nerve Block: The study aims are: * Aim 1: Determine if intra-articular injection as source of pain control for TAA lowers postoperative pain as measured by self-reported narcotic use and pain vs. the peripheral nerve block. * Aim 2: Evaluate differences in functional outcomes and health related quality of life between intra-articular injections and peripheral nerve block as reported by pre- and post-operative patient questionnaires Patients who consent to participate will complete study activities pre-operatively, and at 2 weeks, 6 weeks, and 3 months post-operatively.
Interventions
PROCEDUREIntra-articular injection
Intra-articular injection at the completion of TAA procedure.
PROCEDUREPeripheral nerve block
Pre-operative peripheral nerve block.
Sponsors
Slocum Center for Orthopedics and Sports Medicine
Slocum Research & Education Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient is 40 - 80 years old * Patient is having a primary, unilateral TAA * Patient has signed the current, Institutional Review Board approved informed consent document
Exclusion criteria
* Patient has untreated endocrine disease * Patient has uncontrolled diabetes; lab result of hemoglobin A1c level \> 8.0 mg/dL * Patient has significant heart, liver, kidney or respiratory disease * Patient has peripheral vascular disease * Patient has active cancer * Patient has current history of narcotic use beyond that of oral medications * Patient discharge status is known to be to care facility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total narcotic use in morphine equivalents | Up to 3 months post-operatively | Narcotic dose and frequency captured through patient diary; used to calculate morphine equivalents. |
| Self-reported pain captured with a visual analog pain scale | Up to 3 months post-operatively | Measures self-reported pain between 0 (no pain) and 100 (extreme pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Foot and Ankle Ability Measure (FAAM) | Up to 3 months post-operatively | Measures self-reported outcomes accessing physical function for individuals with foot and ankle related impairments. |
| American Orthopaedic Foot and Ankle Society (AOFAS) Ankle Hindfoot Score | Up to 3 months post-operatively | Grades ankle, subtalar, talonavicular, and calcaneocuboid joint levels in terms of pain (40 points), function (50 points), and alignment (10 points); 100 points possible sub-scores are summed, higher indicates better outcome. |
| Veterans Rand (VR) 36 item Health Survey | Up to 3 months post-operatively | VR-36 Consists of select items from eight concepts of health in the VR-36, measuring health-related quality of life, and differences in disease burden. |
| Time to narcotic discontinuation | Up to 3 months post-operatively | Number of days narcotics were taken for post-operative pain control |
Countries
United States
Contacts
Primary ContactErin C Owen, PhD
Backup ContactMichelle Bremer, BS
Outcome results
None listed