← Back to Search

Device

PNS for Knee Surgery Pain

N/A

Waitlist Available

Research Sponsored by SPR Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 21 years old

Knee pain directly resulting from Knee Replacement surgery in affected knee

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1-week post-sot thru 4-weeks post-sot, 5-weeks post-sot thru 8-weeks post-sot, 3-months post-sot, 6-months post-sot, 9-months post-sot, 12-months post-sot

Awards & highlights

Study Summary

This trial will investigate whether using electrical stimulation on the nerves in the leg can help reduce knee pain.

Who is the study for?

This trial is for adults over 21 who've had a primary, secondary, or partial knee replacement and are experiencing pain from the surgery. It's not suitable for those with high opioid use, BMI over 40, electronic implants, bleeding/clotting disorders, pregnancy, risk of infection or uncontrolled diabetes.Check my eligibility

What is being tested?

The study tests how well the SPRINT PNS System relieves post-operative knee pain by delivering small electrical currents to leg nerves. This device is FDA-cleared for managing acute and chronic pain in the back/extremities for up to 60 days.See study design

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, skin irritation or allergic reaction to adhesive materials used with the device. There could also be temporary muscle twitching during stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am at least 21 years old.

Select...

My knee pain is due to my knee replacement surgery.

Select...

I have had a knee replacement surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1-week post-sot thru 4-weeks post-sot, 5-weeks post-sot thru 8-weeks post-sot, 3-months post-sot, 6-months post-sot, 9-months post-sot, 12-months post-sot

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1-week post-sot thru 4-weeks post-sot, 5-weeks post-sot thru 8-weeks post-sot, 3-months post-sot, 6-months post-sot, 9-months post-sot, 12-months post-sot

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1-week post-sot thru 4-weeks post-sot, 5-weeks post-sot thru 8-weeks post-sot, 3-months post-sot, 6-months post-sot, 9-months post-sot, 12-months post-sot for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reduction in average pain intensity

Study-Related Adverse Device Effects

Secondary outcome measures

Average pain intensity

Function (i.e. physical recovery)

Long-term durability of average pain intensity

+6 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Group 1 (Treatment)Active Control1 Intervention

Participants in Group 1 will have Leads placed by the nerves of the mid to upper thigh. These participants will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and will receive electrical stimulation for 8 weeks.

Group II: Group 2 (Control)Placebo Group1 Intervention

Participants in Group 2 will have Leads placed by the nerves of the mid to upper thigh. These participants will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and receive 8 weeks of sham stimulation. Participants will then have the option to crossover and receive stimulation therapy.

0 / 3Eligibility criteria met