Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation (PNS) System

• Sponsor: SPR Therapeutics, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04341948
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 150
• Locations: 10
• Arms: 2
• Anticipated Duration (Months): 24.8
• Patients Per Site: 15
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to gather information about how knee pain changes when small amounts of electricity are delivered to the nerves in the leg. This study will involve the use of a Peripheral Nerve Stimulation (PNS) System that is made by SPR Therapeutics (the sponsor of the study). The SPRINT PNS System was cleared by the FDA for up to 60 days of use in the back and/or extremities for the management of acute and chronic pain.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain; Total Knee Replacement; Total Knee Arthroplasty; Partial Knee Replacement	Device: SPRINT Peripheral Nerve Stimulation (PNS) System	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation (PNS) System in a Randomized, Double-Blinded, Placebo-Controlled Trial
• Actual Study Start Date: Aug 6, 2020
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 (Treatment) 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.	Device: SPRINT Peripheral Nerve Stimulation (PNS) System; The SPRINT System delivers mild electrical stimulation to nerves in the affected limb. The SPRINT System includes two small wires (called "Leads") that are placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).; Other Names: SPRINT SPRINT System
Sham Comparator: Group 2 (Control) 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.	Device: SPRINT Peripheral Nerve Stimulation (PNS) System; The SPRINT System delivers mild electrical stimulation to nerves in the affected limb. The SPRINT System includes two small wires (called "Leads") that are placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).; Other Names: SPRINT SPRINT System

Outcome Measures

Primary Outcome Measures

1. Reduction in average pain intensity [Baseline and 5-weeks post-Start of Treatment (SOT) thru 8-weeks post-SOT]

   Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).

2. Study-Related Adverse Device Effects [During Lead placement at SOT]

   Occurrence and type of study-related AEs

3. Study-Related Adverse Device Effects [24-48 hours post-Lead placement]

   Occurrence and type of study-related AEs

4. Study-Related Adverse Device Effects [1-week post-SOT]

   Occurrence and type of study-related AEs

5. Study-Related Adverse Device Effects [2-weeks post-SOT]

   Occurrence and type of study-related AEs

6. Study-Related Adverse Device Effects [3-weeks post-SOT]

   Occurrence and type of study-related AEs

7. Study-Related Adverse Device Effects [4-weeks post-SOT]

   Occurrence and type of study-related AEs

8. Study-Related Adverse Device Effects [5-weeks post-SOT]

   Occurrence and type of study-related AEs

9. Study-Related Adverse Device Effects [6-weeks post-SOT]

   Occurrence and type of study-related AEs

10. Study-Related Adverse Device Effects [7-weeks post-SOT]

    Occurrence and type of study-related AEs

11. Study-Related Adverse Device Effects [8-weeks post-SOT]

    Occurrence and type of study-related AEs

12. Study-Related Adverse Device Effects [3-months post-SOT]

    Occurrence and type of study-related AEs

13. Study-Related Adverse Device Effects [6-months post-SOT]

    Occurrence and type of study-related AEs

14. Study-Related Adverse Device Effects [9-months post-SOT]

    Occurrence and type of study-related AEs

15. Study-Related Adverse Device Effects [12-months post-SOT]

    Occurrence and type of study-related AEs

16. Study-Related Adverse Device Effects [During Lead placement at Start of optional Crossover Treatment (SOCT)]

    Occurrence and type of study-related AEs

17. Study-Related Adverse Device Effects [24-48 hours post-Lead placement SOCT]

    Occurrence and type of study-related AEs

18. Study-Related Adverse Device Effects [2-weeks post-SOCT]

    Occurrence and type of study-related AEs

19. Study-Related Adverse Device Effects [4-weeks post-SOCT]

    Occurrence and type of study-related AEs

20. Study-Related Adverse Device Effects [8-weeks post-SOCT]

    Occurrence and type of study-related AEs

21. Study-Related Adverse Device Effects [3-months post-SOCT]

    Occurrence and type of study-related AEs

22. Study-Related Adverse Device Effects [6-months post-SOCT]

    Occurrence and type of study-related AEs

23. Study-Related Adverse Device Effects [9-months post-SOCT]

    Occurrence and type of study-related AEs

24. Study-Related Adverse Device Effects [12-months post-SOCT]

    Occurrence and type of study-related AEs

Secondary Outcome Measures

1. Average pain intensity [Baseline, 1-week post-SOT thru 4-weeks post-SOT]

   Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).

2. Mean pain relief [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]

   Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).

3. Long-term durability of average pain intensity [Baseline, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT]

   Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).

4. Pain medication usage [Baseline, 1-week post-SOT thru 4-weeks post-SOT, and 5-weeks post thru SOT-8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT]

   Medications collected for each diary collection period

5. Pain Catastrophizing Scale (PCS) [Baseline, 4-weeks post-SOT, 8-weeks post-SOT]

   PCS is a 13-question instrument to assess rumination (4 questions), magnification (3 questions), and helplessness (6 questions).

6. Patient Global Impression of Change (PGIC) [4-weeks post-SOT, 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT]

   PGIC assesses the patient's impression of change in quality of life.

7. Pain interference [Baseline, 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT]

   Measured using the average pain interference (question 9 from the Brief Pain Inventory-SF, BPI-9).

8. Function (i.e. physical recovery) [Baseline, 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT]

   Measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

9. Six Minute Walk Test (6MWT) [Baseline, 8-weeks post-SOT, 3-months post-SOT]

   The 6MWT measures the distance walked in 6 minutes and will be used to assess walking speed and endurance.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• At least 21 years old

• Underwent a 1. primary total knee replacement (TKR), 2. secondary/revision TKR or 3. Partial/unicompartmental knee replacement (PKR)

• Knee pain directly resulting from Knee Replacement surgery in affected knee

Key Exclusion Criteria:

• Current high opioid use

• Body Mass Index (BMI) > 40 kg/m2

• Conditions with increased risk of infection

• Implanted electronic device

• History of bleeding or clotting disorder.

• Uncontrolled Diabetes Mellitus Types I or II

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
2	University of California San Diego	San Diego	California	United States	92103
3	The Orthopaedic Institute	Gainesville	Florida	United States	32607
4	Better Health Clinical Research, Inc	Newnan	Georgia	United States	30265
5	NorthShore University HealthSystem	Evanston	Illinois	United States	60201
6	Neuroscience Research Center, LLC	Overland Park	Kansas	United States	66210
7	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70115
8	Ali K. Valimahomed MD PLLC	Holmdel	New Jersey	United States	07733
9	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599
10	Duke University	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• SPR Therapeutics, Inc.
• United States Department of Defense

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SPR Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04341948
• Other Study ID Numbers: 0150-CSP-000; CDMRP-OR170165
• First Posted: Apr 10, 2020
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by SPR Therapeutics, Inc.: Pain, Postoperative; Musculoskeletal Diseases; Postoperative Complications; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Jul 19, 2022