ENABLE: Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA

• Sponsor: 3M (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04712019
• Collaborator: (none)
• Enrollment: 10
• Locations: 6
• Arms: 2
• Anticipated Duration (Months): 22.8
• Patients Per Site: 1.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study will compare the effects of closed incision negative pressure dressing vs. standard of care silver dressing on lower limb swelling after bilateral primary total knee arthroplasty.

Condition or Disease	Intervention/Treatment	Phase
Surgical Wound; Bilateral Total Knee Arthroplasty; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Edema Leg; Joint Pain; Arthritis Knee	Device: Closed Incision Negative Pressure Therapy (ciNPT); Device: Standard Silver-containing Dressing	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: One leg receives ciNPT and the other leg receives standard silver containing dressing.One leg receives ciNPT and the other leg receives standard silver containing dressing.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial Evaluating Edema and ROM Using Negative Pressure Therapy Over Closed Incisions and Surrounding Soft Tissue Versus Standard Surgical Dressings in Bilateral Total Knee Arthroplasty: A Pilot Study
• Actual Study Start Date: Nov 6, 2020
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Closed Incision Negative Pressure Therapy (ciNPT) Dressing Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit	Device: Closed Incision Negative Pressure Therapy (ciNPT); Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision; Other Names: Prevena Restor ArthroForm Prevena Plus 125 Therapy Unit
Active Comparator: Standard Silver-containing Dressing	Device: Standard Silver-containing Dressing; A standard silver-containing dressing applied to a closed surgical incision

Outcome Measures

Primary Outcome Measures

1. Percent Change in Lower Limb Volume [5-7 days after bilateral TKA procedure]

   Percent change in lower limb volume as calculated using manual circumference measurements

Secondary Outcome Measures

1. Percent Change in Lower Limb Volume [12-14 days after bilateral TKA procedure]

   Percent change in lower limb volume as calculated using manual circumference measurements

2. Percent Change in Lower Limb Volume [35-49 days after bilateral TKA procedure]

   Percent change in lower limb volume as calculated using manual circumference measurements

3. Percent Change in Lower Limb Volume [77-91 days after bilateral TKA procedure]

   Percent change in lower limb volume as calculated using manual circumference measurements

4. Percent Change in Lower Limb Circumference [5-7 days after bilateral TKA procedure]

   Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella, 10cm below the center of the patella and 1cm above medial malleolus of ankle

5. Percent Change in Lower Limb Circumference [12-14 days after bilateral TKA procedure]

   Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella, 10cm below the center of the patella and 1cm above medial malleolus of ankle

6. Percent Change in Lower Limb Circumference [35-49 days after bilateral TKA procedure]

   Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella, 10cm below the center of the patella and 1cm above medial malleolus of ankle

7. Percent Change in Lower Limb Circumference [77-91 days after bilateral TKA procedure]

   Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella, 10cm below the center of the patella and 1cm above medial malleolus of ankle

8. Change in Knee Flexion Angle [5-7 days after bilateral TKA procedure]

   Change in knee flexion angle

9. Change in Knee Flexion Angle [12-14 days after bilateral TKA procedure]

   Change in knee flexion angle

10. Change in Knee Flexion Angle [35-49 days after bilateral TKA procedure]

    Change in knee flexion angle

11. Change in Knee Flexion Angle [77-91 days after bilateral TKA procedure]

    Change in knee flexion angle

12. Change in Knee Extension Angle [5-7 days after bilateral TKA procedure]

    Change in knee extension angle

13. Change in Knee Extension Angle [12-14 days after bilateral TKA procedure]

    Change in knee extension angle

14. Change in Knee Extension Angle [35-49 days after bilateral TKA procedure]

    Change in knee extension angle

15. Change in Knee Extension Angle [77-91 days after bilateral TKA procedure]

    Change in knee extension angle

16. Change of Total Range of Motion in Degrees [5-7 days after bilateral TKA procedure]

    Change of total ROM degrees, defined as the flexion angle minus the extension angle

17. Change of Total Range of Motion in Degrees [12-14 days after bilateral TKA procedure]

    Change of total ROM degrees, defined as the flexion angle minus the extension angle

18. Change of Total Range of Motion in Degrees [35-49 days after bilateral TKA procedure]

    Change of total ROM degrees, defined as the flexion angle minus the extension angle

19. Change of Total Range of Motion in Degrees [77-91 days after bilateral TKA procedure]

    Change of total ROM degrees, defined as the flexion angle minus the extension angle

20. Incidence of Surgical Site Complications (SSCs) [within 49 days of bilateral TKA procedure]

    Incidence of surgical site complications defined as: Superficial Surgical Site Infection (SSI) Deep SSI Full thickness skin dehiscence Seroma or hematoma requiring drainage or surgery Skin necrosis Continued drainage at the time of dressing removal

21. Incidence of Surgical Site Complications (SSCs) [within 91 days of bilateral TKA procedure]

    Incidence of surgical site complications defined as: Superficial Surgical Site Infection (SSI) Deep SSI Full thickness skin dehiscence Seroma or hematoma requiring drainage or surgery Skin necrosis Continued drainage at the time of dressing removal

22. Scar assessment [5-7 days after bilateral TKA procedure]

    Evaluation of wound and scar using scar cosmesis assessment

23. Scar assessment [12-14 days after bilateral TKA procedure]

    Evaluation of wound and scar using scar cosmesis assessment

24. Scar assessment [35-49 days after bilateral TKA procedure]

    Evaluation of wound and scar using scar cosmesis assessment

25. Scar assessment [77-91 days after bilateral TKA procedure]

    Evaluation of wound and scar using scar cosmesis assessment

26. Average pain rating on 0-10 scale [Daily for 4 weeks post-surgery, then weekly for weeks 5-12]

    Average pain in each leg using NPRS rating scale

27. Worst pain rating on 0-10 scale [Daily for 4 weeks post-surgery, then weekly for weeks 5-12]

    Worst pain in last 24 hours for each leg using NPRS rating scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• is at least 22 years of age on the date of informed consent.

• can independently provide informed consent.

• requires and is scheduled to undergo a simultaneous, bilateral, primary TKA.

• is willing and physically capable of undergoing a simultaneous, bilateral, primary TKA with or without replacement of the patella.

• is willing and able to return for all scheduled study visits.

Exclusion Criteria:

• is pregnant or lactating.

• has signs of an infection in the area of either knee or has signs of a systemic infection at the time of surgery.

• is a chronic opioid user, defined per the CDC guidelines as opioid use for >3 months, at the time of enrollment.

• has a current diagnosis of lymphedema in either leg.

• has signs, symptoms, or a current diagnosis of venous insufficiency in either leg, as determined by the investigator's review of the subject's medical history.

• has a history of clotting disorder or prior history of deep vein thrombosis

• will undergo a unilateral TKA.

• will undergo a staged, bilateral TKA.

• has had previous knee replacement surgery.

• has received a corticosteroid injection into either knee within 30 days of surgery.

• undergoes a simultaneous, bilateral TKA with a planned different incision type on each knee (eg, midline incision vs. medial parapatellar incision).

• has known sensitivity to the study product components (drape and/or dressing materials in direct contact with the closed incision or skin).

• has known sensitivity to silver.

• is enrolled in another interventional clinical study.

• has skin cancer localized at or in proximity to the incision site.

• does not have access to an electronic device (smartphone, iPad, or computer) on a daily basis to complete online assessments.

• has condition(s) that, in the opinion of the investigator, cause the subject to be an overall health risk that is unsuitable for the surgery.

• has condition(s) that, in the opinion of the investigator, will impact study endpoints (eg, hemophilia or autoimmune disorders) or the ability to comply with study procedures.

Intra-Op Exclusion Criteria:

• does not receive a "total" knee replacement for first knee. For example, a partial or uni-compartmental knee replacement is performed

• has a surgical incision that would preclude placement of either dressing onto the knee

• has a TKA resulting in a muscle flap

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anne Arundel Medical Center	Annapolis	Maryland	United States	21401
2	Rubin Institute for Advanced Orthopedics	Baltimore	Maryland	United States	21215
3	Johns Hopkins Orthopaedics	Columbia	Maryland	United States	21044
4	Northwell Health - Southside Hospital	Bay Shore	New York	United States	11706
5	Northwell Health - Lenox Hill Hospital	New York	New York	United States	10075
6	Northwell Health - Long Island Jewish Valley Stream	Valley Stream	New York	United States	11580

Sponsors and Collaborators

• 3M

Investigators

• Principal Investigator: Fred Cushner, MD, Hospital for Special Surgery, New York

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: 3M
• ClinicalTrials.gov Identifier: NCT04712019
• Other Study ID Numbers: PREVENA.RESTOR.ARTHRO.2019.01
• First Posted: Jan 15, 2021
• Last Update Posted: Aug 2, 2022
• Last Verified: Aug 1, 2022

• 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
• Additional relevant MeSH terms: Joint Diseases; Musculoskeletal Diseases; Arthralgia; Edema; Wounds and Injuries; Surgical Wound

Study Results

No Results Posted as of Aug 2, 2022