Amnion-Based Injections in the Shoulder

NCT03770546 | Withdrawn

• 1 other identifier: IRB-300002242
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) of the shoulder is a common debilitating condition affecting up to 5% of the general population and as much as 32% of patients over 60 years of age. Clinically, OA is diagnosed by a combination of symptoms, such as slow onset of progressively worsening shoulder pain and stiffness over months to years (often with a history of minor trauma), and pain with activity. Physical exam may show tenderness and swelling, muscle atrophy, and decreased range of motion. Adhesive capsulitis (also called "Frozen Shoulder") is another common shoulder condition, affecting 2-5% of the general population. Frozen shoulder presents with a similar combination of symptoms, such as inability to sleep on the side of the affected shoulder, shoulder pain, and pain at extremes of active and passive range of motion. Despite the ubiquitous nature of these conditions, various non-operative treatment modalities have been employed in their managements without a clearly superior alternative. The usual initial treatment strategy for both of these conditions is the same: a trial of conservative management. Conservative management includes physical therapy, supervised neglect, over-the-counter pain medications (including NSAIDs, like Advil), oral and intra-articular corticosteroid use (steroids), hydrodilatation (capsular distension to rupture), intra-articular hyaluronic acid injections. Despite several years of employing different modes of treatment, there is no evidence that places one treatment modality over the others, and patients will often need surgery. Amniotic fluid's apparent ability to improve blood flow, re-organize collagen, and protect cartilage makes it theoretically ideal for disorders like osteoarthritis and frozen shoulder. In recent studies, it has shown efficacy in promoting ligament healing in the knee and promoting tendon and degenerative joint pain reduction and functional improvement. It has been useful as a material for cartilage repair when used as a scaffold. Intra-articular amnion membrane injection may have favorable outcomes in patients with osteoarthritis of the shoulder or frozen shoulder. To test this hypothesis, intra-articular amnion will be injected into the shoulders of 20 patients with moderate to severe osteoarthritis and 20 patients with frozen shoulder. The hypothesis is that improvement in short-term outcomes (pain, function, and range of motion) will be identified following amnion injection in these patients. The goal of this study is to lead to larger randomized controlled trials evaluating amnion against current forms of treatment for osteoarthritis.

Conditions

Osteoarthritis of the Shoulder; Adhesive Capsulitis

Outcome Measures

Primary Outcomes (2)

• Range of Motion

  Measured via goniometer

  0-12 months after injection

• Strength

  Measured via dynamometer

  0-12 months after injection

Secondary Outcomes (6)

• Shoulder Pain and Disability Index for shoulder pain and function

  0-12 months after injection

• Short-Form Health Survey 36 for physical health, mental health, pain and limitation of activities

  0-12 months after injection

• American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form of shoulder function

  0-12 months after injection

• Simple Shoulder Test of shoulder function

  0-12 months after injection

• Disabilities of the Arm, Shoulder, and Hand Questionnaire of arm, shoulder, and hand function

  0-12 months after injection

Study Arms (4)

Osteoarthritis - Amnion Injection

EXPERIMENTAL

BioDRestore Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from human amniotic tissues.

Biological: Amnion Injection

Osteoarthritis - Betamethasone Injection

ACTIVE COMPARATOR

Betamethasone Sodium Phosphate and Betamethasone Acetate injection (To clarify, this is one formulation/injected solution, not separate solutions/interventions)

Drug: Betamethasone injection

Adhesive Capsulitis - Amnion Injection

EXPERIMENTAL

BioDRestore Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from human amniotic tissues.

Biological: Amnion Injection

Adhesive Capsulitis - Betamethasone Injection

ACTIVE COMPARATOR

Betamethasone Sodium Phosphate and Betamethasone Acetate injection (To clarify, this is one formulation/injected solution, not separate solutions/interventions)

Drug: Betamethasone injection

Interventions

Amnion Injection BIOLOGICAL

Per the manufacturer, this is considered an injection of tissue/organic matter.

Adhesive Capsulitis - Amnion Injection; Osteoarthritis - Amnion Injection

Betamethasone injection DRUG

Routine steroid injection for these pathologies. Betamethasone Sodium Phosphate and Betamethasone Acetate injection.

Adhesive Capsulitis - Betamethasone Injection; Osteoarthritis - Betamethasone Injection

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or greater
• Clinical diagnosis of adhesive capsulitis, clinically in the frozen phase at the time of enrollment OR Clinical diagnosis of osteoarthritis of the shoulder.
• Symptoms for 2-6 months
• Failure of conservative management.
• \> 25% reduction in active range of motion in \>= 2/3 planes of motion in the affected shoulder.
• No alternative medical explanation for symptoms

You may not qualify if:

• Alternative explanation for symptoms including neurological disorders, or like conditions
• Pregnancy or desire to become pregnant
• Discretion of the enrolling clinician
• Intra-articular steroid injection within 6 months of enrollment or surgical intervention in the within 12 months of enrollment in affected shoulder

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

Related Publications (8)

• Bal A, Eksioglu E, Gulec B, Aydog E, Gurcay E, Cakci A. Effectiveness of corticosteroid injection in adhesive capsulitis. Clin Rehabil. 2008 Jun;22(6):503-12. doi: 10.1177/0269215508086179.

  PMID: 18511530 BACKGROUND

• Carette S, Moffet H, Tardif J, Bessette L, Morin F, Fremont P, Bykerk V, Thorne C, Bell M, Bensen W, Blanchette C. Intraarticular corticosteroids, supervised physiotherapy, or a combination of the two in the treatment of adhesive capsulitis of the shoulder: a placebo-controlled trial. Arthritis Rheum. 2003 Mar;48(3):829-38. doi: 10.1002/art.10954.

  PMID: 12632439 BACKGROUND

• Lorbach O, Anagnostakos K, Scherf C, Seil R, Kohn D, Pape D. Nonoperative management of adhesive capsulitis of the shoulder: oral cortisone application versus intra-articular cortisone injections. J Shoulder Elbow Surg. 2010 Mar;19(2):172-9. doi: 10.1016/j.jse.2009.06.013. Epub 2009 Oct 1.

  PMID: 19800262 BACKGROUND

• Willett NJ, Thote T, Lin AS, Moran S, Raji Y, Sridaran S, Stevens HY, Guldberg RE. Intra-articular injection of micronized dehydrated human amnion/chorion membrane attenuates osteoarthritis development. Arthritis Res Ther. 2014 Feb 6;16(1):R47. doi: 10.1186/ar4476.

  PMID: 24499554 BACKGROUND

• Vines JB, Aliprantis AO, Gomoll AH, Farr J. Cryopreserved Amniotic Suspension for the Treatment of Knee Osteoarthritis. J Knee Surg. 2016 Aug;29(6):443-50. doi: 10.1055/s-0035-1569481. Epub 2015 Dec 18.

  PMID: 26683979 BACKGROUND

• Kerimoglu S, Livaoglu M, Sonmez B, Yulug E, Aynaci O, Topbas M, Yarar S. Effects of human amniotic fluid on fracture healing in rat tibia. J Surg Res. 2009 Apr;152(2):281-7. doi: 10.1016/j.jss.2008.02.028. Epub 2008 Mar 18.

  PMID: 18499130 BACKGROUND

• Raines AL, Shih MS, Chua L, Su CW, Tseng SC, O'Connell J. Efficacy of Particulate Amniotic Membrane and Umbilical Cord Tissues in Attenuating Cartilage Destruction in an Osteoarthritis Model. Tissue Eng Part A. 2017 Jan;23(1-2):12-19. doi: 10.1089/ten.TEA.2016.0088. Epub 2016 Nov 18.

  PMID: 27707109 BACKGROUND

• Zelen CM, Poka A, Andrews J. Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis--a feasibility study. Foot Ankle Int. 2013 Oct;34(10):1332-9. doi: 10.1177/1071100713502179. Epub 2013 Aug 14.

  PMID: 23945520 BACKGROUND

MeSH Terms

Conditions

Bursitis

Interventions

Betamethasone

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Orthopaedic Surgery

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: December 10, 2018
• Study Start: October 30, 2021
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: November 26, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)