Trial Outcomes & Findings for An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study (NCT NCT00198029)

NCT ID: NCT00198029

Last Updated: 2017-04-17

Results Overview

The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. Scores are transformed to a 0-100 scale, with a higher value indicating greater disability. The change in DASH (delta) over those 6 months was recorded.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: 26 weeks (6 months)
• Results posted on: 2017-04-17

Participant Flow

Patients with painful CMC OA and radiographic changes of Kellgren and Lawrence (K+L) Grade 2-4 were recruited from rheumatology and hand surgery practices at the Hospital for Special Surgery from 2004-2005

Exclusion criteria included: age < 45, systemic rheumatic disease, self-reported comorbid hand conditions, history of gout or pseudogout, bleeding diatheses, previous surgery to the involved thumb, and no evidence of CMC joint space narrowing. Patients must have failed some form of conservative therapy, such as NSAIDS, acetaminophen or splinting.

Participant milestones

Measure	Synvisc Group Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections.
Overall Study STARTED	32
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Synvisc Group Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections.
Overall Study Withdrawal by Subject	4

Baseline Characteristics

An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study

Baseline characteristics by cohort

Measure	Open Label Group n=32 Participants Thirty-two patients were injected over ten months with Synvisc and followed for 6 months post injections.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants
Age, Continuous	64 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants

PRIMARY outcome

Timeframe: 26 weeks (6 months)

The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. Scores are transformed to a 0-100 scale, with a higher value indicating greater disability. The change in DASH (delta) over those 6 months was recorded.

Outcome measures

Measure	Synvisc Group n=32 Participants Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections.
The Disabilities of the Arm, Shoulder and Hand Outcome Measure	12.6 units on a scale Standard Deviation 17.2

SECONDARY outcome

Timeframe: 26 weeks (6 months)

The visual analog scale for pain (VAS) is a test requiring a patient to indicate along a line how much pain they are experiencing between 0-100. A score of 100 indicates the maximum possible pain level and a score of 0 indicates no pain. Scores are recorded as whole number integers. The change in VAS (delta) over those 6 months was recorded.

Outcome measures

Measure	Synvisc Group n=32 Participants Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections.
Visual Analog Scale for Pain	15.2 mm Standard Deviation 29.5

Adverse Events

Open Label Group

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Open Label Group n=32 participants at risk Thirty-two patients were injected over ten months with Synvisc and followed for 6 months post injections.
Musculoskeletal and connective tissue disorders Unlikely Related Pseudogout	3.1% 1/32 • Number of events 1
Gastrointestinal disorders Unlikely Related GI Bleed	3.1% 1/32 • Number of events 1
Musculoskeletal and connective tissue disorders Possibly but Unlikely Related Fall	3.1% 1/32 • Number of events 1

Other adverse events

Measure	Open Label Group n=32 participants at risk Thirty-two patients were injected over ten months with Synvisc and followed for 6 months post injections.
Musculoskeletal and connective tissue disorders Pain at Injection Site	9.4% 3/32 • Number of events 96

Additional Information

Dr. Lisa Mandl

Hospital for Special Surgery

Phone: 212-774-2555

Email: MandlL@hss.edu

Results disclosure agreements

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