Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis

• Sponsor: Hospital for Special Surgery, New York (Other)
• Overall Status: Completed
• CT.gov ID: NCT02984228
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 71
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

This study seeks to expand the current literature in demonstrating potentially efficacious, conservative treatments in the management of glenohumeral osteoarthritis (OA) and will compare ultrasound-guided injections of hyaluronic acid vs. platelet-rich plasma. We aim to obtain information measuring potential benefits of these interventions and to observe for any adverse events.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; Shoulder Pain	Biological: PRP; Drug: Hyaluronic Acid; Device: Ultrasound	Phase 4

Detailed Description

Glenohumeral OA accounts for approximately 2-5% of all chronic shoulder pain and may be classified into primary and secondary forms. Primary glenohumeral OA is caused by degenerative joint disease, inflammatory arthropathies, and neuropathic arthropathy secondary to syringomyelia or diabetes. Secondary glenohumeral OA is caused by trauma, postoperative changes after arthroscopy or capulorraphy, and osteonecrosis. Hyaluronic acid is found in synovial joint fluid and has viscoelastic, chondroprotective, and possibly anti-inflammatory properties. It has been shown to increase joint lubrication. Platelet-rich plasma contains growth factors that have been shown to promote tissue regeneration. The aim of this study is to determine whether injections of hyaluronic acid or platelet-rich plasma can be used reliably to decrease pain, restore function, and improve quality of life in patients suffering from glenohumeral OA. Patients will be randomized to receive either an injection of hyaluronic acid or an injection of platelet-rich plasma. Outcomes will be assessed via questionnaires for up to 52 weeks post-procedure.

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Efficacy of Ultrasound Guided Glenohumeral Joint Injections of Platelet Rich Plasma (PRP) Versus Hyaluronic Acid (HA) in the Treatment of Glenohumeral Osteoarthritis: a Randomized, Double-blind Control Trial
• Actual Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Nov 1, 2020
• Actual Study Completion Date: Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Platelet-rich plasma (PRP) Patients will receive an injection of PRP.	Biological: PRP; Device: Ultrasound
Active Comparator: Hyaluronic Acid Patients will receive an injection of hyaluronic acid.	Drug: Hyaluronic Acid; Device: Ultrasound

Outcome Measures

Primary Outcome Measures

1. Shoulder Pain and Disability Index (SPADI) Score [Up to 52 weeks post-procedure]

   Score ranges from 0-100, with a higher score representing higher disability.

Secondary Outcome Measures

1. Shoulder Function [Up to 52 weeks post-procedure]

   Shoulder function will be assessed using the American Shoulder and Elbow Surgeons Society Standardized Shoulder Assessment (ASES) Form. The ASES forms includes questions about difficulty performing different functions, such as putting on a coat and sleeping on the affected side. Scores range from 0 to 100, with a higher score indicating higher function and a lower score indicating lower function.

2. Number of Patients Who Were Satisfied After Treatment [Up to 52 weeks post-procedure]

   Satisfaction will be assessed using the North American Spine Society Patient Satisfaction Index. Patients were asked to select one of the following in regards to the procedure: "The procedure met my expectations"; "The procedure improved my condition enough so that I would go through it again for the same outcome"; "The procedure helped me, but I would not go through it again for the same outcome"; or "I am the same or worse compared to before the procedure". Responses of "The procedure met my expectations" and "The procedure improved my condition enough so that I would go through it again for the same outcome" were considered to be "satisfied". The other two responses were considered to be "not satisfied".

3. Number of Patients With Complication Events After the Procedure [Up to 52 weeks post-procedure]

   Any complications reported were collected. Complications include bleeding from the injection site, prolonged swelling, infection, weakness of the muscles surrounding the injected joint, and allergic reactions. Total number of available events was calculated by multiplying the number of patients with the number of follow-up time points. The percentage of complication events was calculated by summing the number of complication events and dividing that by the total number of available events, and then multiplying by 100.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• English speaking/literate

• Age 18-100 years

• Visual analog score pain >= 5

• Greater than or equal to 3 months of pain after onset of symptoms that has failed conservative treatments

• Confirmation of glenohumeral OA via routine imaging (MRI and x-ray; must be recent and within the past year)

• Transient relief of symptoms after diagnostic intra-articular injection into the glenohumeral joint

Exclusion Criteria:

• Non-English speaking/illiterate

• Painful active, concurrent cervical spine conditions

• Current non-steroidal anti-inflammatory drug (NSAID) use

• History of taking coumadin or similar anticoagulant, have a known coagulopathy, bleeding dyscrasia, or platelet count < 150,000/cubic mm

• Allergic reaction to poultry or previous viscosupplementation

• Involved in workers' compensation or active litigation involving affected shoulder

• Inability to refrain from NSAID use for 5 days prior to and 6 weeks after injection

• History of corticosteroid injection to affected shoulder within the last 3 months

• History of viscosupplementation or platelet-rich plasma to affected shoulder within the last 6 months

• Presence of acute fracture

• History of shoulder tumor

• Known uncontrolled systemic illness (uncontrolled diabetes, human immunodeficiency virus, vasculitis, autoimmune/inflammatory disease)

• Psychiatric and somatoform disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	10021

Sponsors and Collaborators

• Hospital for Special Surgery, New York

Investigators

• Principal Investigator: Jonathan Kirschner, MD, Hospital for Special Surgery, New York

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 28, 2021

More Information

Publications

None provided.

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT02984228
• Other Study ID Numbers: 2015-188
• First Posted: Dec 6, 2016
• Last Update Posted: Aug 8, 2022
• Last Verified: Aug 1, 2022

• Additional relevant MeSH terms: Osteoarthritis; Shoulder Pain; Hyaluronic Acid

Study Results

Participant Flow

Arm/Group Title	Platelet-rich Plasma (PRP)	Hyaluronic Acid
Arm/Group Description	Patients will receive an injection of PRP. PRP Ultrasound	Patients will receive an injection of hyaluronic acid. Hyaluronic Acid Ultrasound
Period Title: Overall Study
STARTED	34	36
COMPLETED	34	35
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Platelet-rich Plasma (PRP)	Hyaluronic Acid	Total
Arm/Group Description	Patients will receive an injection of PRP. PRP Ultrasound	Patients will receive an injection of hyaluronic acid. Hyaluronic Acid Ultrasound	Total of all reporting groups
Overall Participants	34	36	70
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.1 (11.5)	68.4 (11.9)	68.7 (11.6)
Sex: Female, Male (Count of Participants)
Female	20 58.8%	18 50%	38 54.3%
Male	14 41.2%	18 50%	32 45.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2.9%	1 2.8%	2 2.9%
Not Hispanic or Latino	33 97.1%	35 97.2%	68 97.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 2.8%	1 1.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 2.9%	1 2.8%	2 2.9%
White	33 97.1%	34 94.4%	67 95.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	34 100%	36 100%	70 100%
Severe osteoarthritis (Count of Participants)
Count of Participants [Participants]	21 61.8%	23 63.9%	44 62.9%

Outcome Measures

1. Primary Outcome

Title	Shoulder Pain and Disability Index (SPADI) Score
Description	Score ranges from 0-100, with a higher score representing higher disability.
Time Frame	Up to 52 weeks post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Platelet-rich Plasma (PRP)	Hyaluronic Acid
Arm/Group Description	Patients will receive an injection of PRP. PRP Ultrasound	Patients will receive an injection of hyaluronic acid. Hyaluronic Acid Ultrasound
Measure Participants	34	35
Mean (95% Confidence Interval) [score on a scale]	50.3	49

2. Secondary Outcome

Title	Shoulder Function
Description	Shoulder function will be assessed using the American Shoulder and Elbow Surgeons Society Standardized Shoulder Assessment (ASES) Form. The ASES forms includes questions about difficulty performing different functions, such as putting on a coat and sleeping on the affected side. Scores range from 0 to 100, with a higher score indicating higher function and a lower score indicating lower function.
Time Frame	Up to 52 weeks post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Platelet-rich Plasma (PRP)	Hyaluronic Acid
Arm/Group Description	Patients will receive an injection of PRP. PRP Ultrasound	Patients will receive an injection of hyaluronic acid. Hyaluronic Acid Ultrasound
Measure Participants	34	35
Mean (95% Confidence Interval) [score on a scale]	57.8	59

3. Secondary Outcome

Title	Number of Patients Who Were Satisfied After Treatment
Description	Satisfaction will be assessed using the North American Spine Society Patient Satisfaction Index. Patients were asked to select one of the following in regards to the procedure: "The procedure met my expectations"; "The procedure improved my condition enough so that I would go through it again for the same outcome"; "The procedure helped me, but I would not go through it again for the same outcome"; or "I am the same or worse compared to before the procedure". Responses of "The procedure met my expectations" and "The procedure improved my condition enough so that I would go through it again for the same outcome" were considered to be "satisfied". The other two responses were considered to be "not satisfied".
Time Frame	Up to 52 weeks post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Platelet-rich Plasma (PRP)	Hyaluronic Acid
Arm/Group Description	Patients will receive an injection of PRP. PRP Ultrasound	Patients will receive an injection of hyaluronic acid. Hyaluronic Acid Ultrasound
Measure Participants	34	35
Count of Participants [Participants]	20 58.8%	20 55.6%

4. Secondary Outcome

Title	Number of Patients With Complication Events After the Procedure
Description	Any complications reported were collected. Complications include bleeding from the injection site, prolonged swelling, infection, weakness of the muscles surrounding the injected joint, and allergic reactions. Total number of available events was calculated by multiplying the number of patients with the number of follow-up time points. The percentage of complication events was calculated by summing the number of complication events and dividing that by the total number of available events, and then multiplying by 100.
Time Frame	Up to 52 weeks post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Platelet-rich Plasma (PRP)	Hyaluronic Acid
Arm/Group Description	Patients will receive an injection of PRP. PRP Ultrasound	Patients will receive an injection of hyaluronic acid. Hyaluronic Acid Ultrasound
Measure Participants	34	35
Number [participants]	11 32.4%	13 36.1%

Adverse Events

Time Frame	Adverse event data were collected over 1 year.
Adverse Event Reporting Description	Adverse events included bleeding from the injection site, swelling, infection, allergic reactions, weakness of the muscle surrounding the infected joint. The adverse event percentages noted in this section do not match the ones reported under Outcome Measures, as the Outcome Measures represent the percentage of adverse event cases among all events available (e.g., number of patients * number of follow-up time points).
Arm/Group Title	Platelet-rich Plasma (PRP)		Hyaluronic Acid
Arm/Group Description	Patients will receive an injection of PRP. PRP Ultrasound		Patients will receive an injection of hyaluronic acid. Hyaluronic Acid Ultrasound
All Cause Mortality
	Platelet-rich Plasma (PRP)		Hyaluronic Acid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/35 (0%)
Serious Adverse Events
	Platelet-rich Plasma (PRP)		Hyaluronic Acid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/35 (0%)
Other (Not Including Serious) Adverse Events
	Platelet-rich Plasma (PRP)		Hyaluronic Acid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/34 (32.4%)		13/35 (37.1%)
Immune system disorders
Allergic reaction with itchiness	1/34 (2.9%)		4/35 (11.4%)
Infections and infestations
Infection	0/34 (0%)		2/35 (5.7%)
Musculoskeletal and connective tissue disorders
Weakness of muscle surrounding injection site	9/34 (26.5%)		9/35 (25.7%)
Difficulty moving affected shoulder joint	4/34 (11.8%)		5/35 (14.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.