Cold and Compression After Rotator Cuff Repair (RCR)

Conditions

• High-grade Partial or Full Thickness Rotator Cuff Tears

Eligibility Criteria

Sex

ALL

Age

35 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SOC (Standard of care) — OTHER
  Patients enrolled in this arm will be discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold therapy (bag of ice or gel pack) Other Name:
• Cold and Compression — DEVICE
  External mechanical compression therapy (e.g., compression stockings) has been shown to reduce swelling and risk of deep vein thrombosis in the lower limbs following TKA.12,13 Combining advanced cryotherapy (continuous circulating cold flow) and dynamic compression may offer added benefits than either traditional cryotherapy (e.g., cold packs) or compression (e.g., stockings) alone.

Study Details

The purpose of this study is to compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups pre-surgically, daily after surgery for 14 days, then weekly after surgery for 3 months, and at 6 months post-surgery.

Key Dates

Start date

Mar 1, 2026

Status verified

Apr 2026

Primary completion

Sep 1, 2027

Completion

Aug 31, 2029

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Standard of Care Arm
  Patients in this arm will receive standard therapy post-surgery and discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold therapy (bag of ice or gel pack)
• Experimental: Cold and Compression
  Patients in this arm will be discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold \& compression therapy device provided by Sponsor)

Primary Outcome Measure

PROMIS Pain NRS subscale [ Time Frame: Enrollment to 6 months post RCR ]

Central Contacts

• Richard Hartman, MD
  (504) 412-1705
  [email protected]
• Ken Bode
  504-842-1936
  [email protected]

Locations (1)

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