Effect of Compression Therapy on Postoperative Swelling and Pain After Total Knee Arthroplasty

NCT03490409 | Completed DMC

• 1 other identifier: SJ-635
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The number of severely obese patients who has knee replacement surgery is rising. Obesity increases the risk of the postoperative swelling. A complication which can cause pain and discomfort as well as complicate and prolong rehabilitation. The aim of the present pilot study is to examine the effect of a compression stocking on postoperative swelling and pain among patients with a BMI ≥30 kg/m2, after total knee arthroplasty. The hypothesis is that the use of a medical elastic compression stocking for 14 days postoperatively may reduce postoperative swelling by two cm. The pilot study will furthermore provide useful information for feasibility which will be used to decide whether or not a larger study should be initiated.

Conditions

Edema

Keywords

Arthroplasty; Replacement; Knee; Compression; Edema; Pain

Outcome Measures

Primary Outcomes (1)

• Swelling of the knee after operation

  Measurements will be taken on the day of admission before surgery and at day 1, 2 and 14 days after surgery in millimeters to determine whether swelling has occurred. No predetermined higher or lower values. Higher values represent a worse outcome. Lower values represents a better outcome.

  Assessment of swelling of the knee from baseline and 1, 2, 14 days after surgery

Secondary Outcomes (3)

• Swelling of the calf after the operation.

  Assessment of swelling of the calf from baseline and 1, 2, 14 days after surgery

• Swelling of the ankle after the operation.

  Assessment of the swelling of the ankle from baseline and 1, 2, 14 days after surgery

• Pain after the operation.

  Assessment of pain from baseline and 1, 2, 14 days after surgery

Study Arms (2)

compression stocking

EXPERIMENTAL

The intervention group will receive a thigh compression stocking, which is to be used for 24 hours a day for 14 days after surgery.

Device: Thigh compression stocking

Conventional treatment

NO INTERVENTION

The control group will receive conventional treatment, a compression bandage placed at the end of surgery and removed on the night of the surgery.

Interventions

Thigh compression stocking DEVICE

Thigh compression stocking

compression stocking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned for total knee arthroplasty
• BMI ≥30 kg/m2, aged 18 or older
• Speaks, reads and understands Danish
• Written informed consent.

You may not qualify if:

• Peripheral Arterial Disease
• Arterial insufficiency
• No palpable puls at the arteria dorsalis pedis
• Severe atherosclerosis
• Leg ulcers
• Skin disease
• Fragile "tissue paper" skin
• Neuropathy or other cause of sensory impairment
• Allergy to the stocking material
• Massive leg edema or pulmonary edema from congestive cardiac failure,
• Deformity of the leg or unusual leg shape or size preventing correct fit
• Patient that cannot cooperate. For example does not understand the concept of Visual Analogue Scale (VAS) or is not able to use the compression stocking
• Pregnancy

Sponsors & Collaborators

• Naestved Hospital: lead

Study Sites (1)

Department for planned Orthopaedic Surgery

Næstved, 4700, Denmark

Location

MeSH Terms

Conditions

Edema; Pain

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• Linda Mie Christensen, nurse

  Naestved Sygehus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: April 6, 2018
• Study Start: December 18, 2017
• Primary Completion: April 9, 2018
• Study Completion: April 9, 2018
• Last Updated: June 11, 2018

Record last verified: 2018-06

Locations

DK (1)