The Use of Dehydrated Human Amnion/Chorion Membrane Allograft Injection for the Treatment of Tendinopathy or Arthritis: A Case Series Involving 40 Patients.

BACKGROUND: Degenerative joint and tendon injuries remain difficult to treat, with few effective conservative treatment options available. Regenerative approaches aim to promote the inherent healing capacity of injured tissues. Micronized dehydrated human amnion/chorion membrane (dHACM) injection is an emerging regenerative option with promising preclinical results.

OBJECTIVE: To test the clinical effectiveness of dHACM injection in patients with chronic tendinopathy and arthropathy.

DESIGN: Case series.

SETTING: Academic medical center outpatient sports medicine clinic.

PATIENTS: A total of 40 patients with chronic tendinosis or arthropathy who received dHACM over a period of 9 months.

METHODS: A structured interview was administered to patients by telephone to supplement the clinical information available in the medical chart. All patients received an ultrasound-guided injection of dHACM.

MAIN OUTCOME MEASURES: The primary outcome was change in pain level, and the secondary outcome was change in activities of daily living (ADLs) and sports/recreation function. More than 30% improvement in average pain and function was considered a successful outcome.

RESULTS: Patient pain and function were measured at 1, 2, and 3 months after the procedure. Patient-reported average pain scores decreased from a baseline value of 6.4 (95% confidence interval [CI] = 5.7-7.0) to 2.7 (95% CI = 2.1-3.3; P < .001) at 1 month, 1.7 (95% CI = 1.1-2.2; P < .001) at 2 months, and 1.4 (95% CI = 0.9-1.9; P < .001) at 3 months. The percentage of patients achieving clinical success, defined as 30% or greater improvement in pain levels, was 68% at 1 month, 82% at 2 months, and 91% at 3 months. Patient-reported functional impairment in ADLs decreased from 6.8 (95% CI = 6.0-7.5) to 2.0 (95% CI = 1.4-2.7) (P < .001); impairment in sports/recreation decreased from 8.5 (95% CI = 7.9-9.1) to 3.2 (95% CI = 2.6-3.9) (P < .001). Frequency of pain medication use decreased from 29 of 40 patients (72.5%) before the procedure to 9 of 40 patients (22.5%) at final follow up (P < .001). Localized pain at the injection site was common, but no other adverse events or side effects were reported.

CONCLUSION: In the setting of tendinosis or arthropathy, dHACM injection was clinically effective in reducing pain and improving function in a majority of adults.

LEVEL OF EVIDENCE: IV.