Trial Outcomes & Findings for Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis (NCT NCT02984228)

NCT ID: NCT02984228

Last Updated: 2022-08-08

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 70 participants
• Primary outcome timeframe: Up to 52 weeks post-procedure
• Results posted on: 2022-08-08

Participant Flow

Participant milestones

Measure	Platelet-rich Plasma (PRP) Patients will receive an injection of PRP. PRP Ultrasound	Hyaluronic Acid Patients will receive an injection of hyaluronic acid. Hyaluronic Acid Ultrasound
Overall Study STARTED	34	36
Overall Study COMPLETED	34	35
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis

Baseline characteristics by cohort

Measure	Platelet-rich Plasma (PRP) n=34 Participants Patients will receive an injection of PRP. PRP Ultrasound	Hyaluronic Acid n=36 Participants Patients will receive an injection of hyaluronic acid. Hyaluronic Acid Ultrasound	Total n=70 Participants Total of all reporting groups
Age, Continuous	69.1 years STANDARD_DEVIATION 11.5 • n=5 Participants	68.4 years STANDARD_DEVIATION 11.9 • n=7 Participants	68.7 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	18 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants	35 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	34 Participants n=7 Participants	67 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	36 participants n=7 Participants	70 participants n=5 Participants
Severe osteoarthritis	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 52 weeks post-procedure

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

Outcome measures

Measure	Platelet-rich Plasma (PRP) n=34 Participants Patients will receive an injection of PRP. PRP Ultrasound	Hyaluronic Acid n=35 Participants Patients will receive an injection of hyaluronic acid. Hyaluronic Acid Ultrasound
Shoulder Pain and Disability Index (SPADI) Score	50.3 score on a scale Interval 38.7 to 62.0	49 score on a scale Interval 38.0 to 60.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Platelet-rich Plasma (PRP) n=34 Participants Patients will receive an injection of PRP. PRP Ultrasound	Hyaluronic Acid n=35 Participants Patients will receive an injection of hyaluronic acid. Hyaluronic Acid Ultrasound
Shoulder Function	57.8 score on a scale Interval 47.9 to 68.0	59 score on a scale Interval 46.3 to 68.5

SECONDARY outcome

Timeframe: 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".

Outcome measures

Measure	Platelet-rich Plasma (PRP) n=34 Participants Patients will receive an injection of PRP. PRP Ultrasound	Hyaluronic Acid n=35 Participants Patients will receive an injection of hyaluronic acid. Hyaluronic Acid Ultrasound
Number of Patients Who Were Satisfied After Treatment	20 Participants	20 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Platelet-rich Plasma (PRP) n=34 Participants Patients will receive an injection of PRP. PRP Ultrasound	Hyaluronic Acid n=35 Participants Patients will receive an injection of hyaluronic acid. Hyaluronic Acid Ultrasound
Number of Patients With Complication Events After the Procedure	11 participants	13 participants

Adverse Events

Platelet-rich Plasma (PRP)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Hyaluronic Acid

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Platelet-rich Plasma (PRP) n=34 participants at risk Patients will receive an injection of PRP. PRP Ultrasound	Hyaluronic Acid n=35 participants at risk Patients will receive an injection of hyaluronic acid. Hyaluronic Acid Ultrasound
Musculoskeletal and connective tissue disorders Weakness of muscle surrounding injection site	26.5% 9/34 • Adverse event data were collected over 1 year. 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).	25.7% 9/35 • Adverse event data were collected over 1 year. 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).
Immune system disorders Allergic reaction with itchiness	2.9% 1/34 • Adverse event data were collected over 1 year. 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).	11.4% 4/35 • Adverse event data were collected over 1 year. 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).
Infections and infestations Infection	0.00% 0/34 • Adverse event data were collected over 1 year. 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).	5.7% 2/35 • Adverse event data were collected over 1 year. 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).
Musculoskeletal and connective tissue disorders Difficulty moving affected shoulder joint	11.8% 4/34 • Adverse event data were collected over 1 year. 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).	14.3% 5/35 • Adverse event data were collected over 1 year. 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).

Additional Information

Jennifer Cheng

Hospital for Special Surgery

Phone: 6467146870

Email: chengj@hss.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place