Trial Outcomes & Findings for Efficacy of 3 Weekly Injections of Hyaluronate in Patients With Ankle Osteoarthritis (NCT NCT00918736)

Results Overview

The AOS is a patient-rated, validated outcome measure that includes nine items on a pain subscale and nine items on a disability subscale. Using the AOS, a score of 0 represent no pain or disability and 10 represent worst pain or disability imaginable

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

baseline and 6 months

Results posted on

2009-06-17

Participant Flow

Fifty patients fulfilled the inclusion criteria and consented to take part in this study.

One patient withdrew his consent and one had a fear of injection prior to receiving the first injection. Two patients withdrew from the study before the third injection (one because of an unrelated intercurrent illness and one moving to another city).

Participant milestones

Participant milestones
Measure	Hyaluronate Injection All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
Overall Study STARTED	50
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Hyaluronate Injection All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Efficacy of 3 Weekly Injections of Hyaluronate in Patients With Ankle Osteoarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hyaluronate Injection n=50 Participants All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age Continuous	51.7 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment Taiwan	50 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

Population: The statistical analysis was done on completers.

The AOS is a patient-rated, validated outcome measure that includes nine items on a pain subscale and nine items on a disability subscale. Using the AOS, a score of 0 represent no pain or disability and 10 represent worst pain or disability imaginable

Outcome measures

Outcome measures
Measure	Hyaluronate Injection n=46 Participants All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
Change From Baseline in the Ankle Osteoarthritis Scale (AOS) Score at 6 Months	2.3 score on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: 6 months

The American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score is a 100-point scale that devotes 40 points to pain, 50 points to function and 10 points to alignment. The maximum score of 100 points denotes no pain and normal function and alignment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Ankle sagittal ROM is the sum of ankle dorsiflexion and plantar flexion angles.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Single-leg stance test (SLS),The Functional Reach Test (FRT),Timed " Up-and-Go" test (TUG) ,Berg Balance Scale (BBS)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

The rating was based on a 7-point categorical scale weighted from completely satisfied, satisfied, somewhat satisfied, no change, somewhat unsatisfied, unsatisfied to completely unsatisfied.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

he occurrence of systemic and local adverse events, defined as any unwanted events whether it was thought to be related to the study drugs or not, were recorded on a diary card

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

The use of all analgesic medication during the study period was recorded on a diary card by the patient.

Outcome measures

Outcome data not reported

Adverse Events

Hyaluronate Injection

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Hyaluronate Injection All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
Skin and subcutaneous tissue disorders brief post injection pain	100.0% 3/3 • Number of events 3
Skin and subcutaneous tissue disorders local pruritis	100.0% 1/1 • Number of events 1

Additional Information

Shu-Fen Sun

Veterans General Hospital, Kaohsiung, Taiwan

Phone: 886-73422121

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place