A randomized controlled trial on effects of Cryo/Cuff in early rehabilitation of total knee arthroplasty

Completed

Conditions: Degenerative knee joint osteoarthritis
Musculoskeletal Diseases
Osteoarthritis

Registration Number: ISRCTN12615549

Lead Sponsor: Peking Union Medical College Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 98

Inclusion Criteria

1. Aged 18 to 80 years
2. Degenerative osteoarthritis need for total knee arthroplasty
3. Initial unilateral total knee arthroplasty patients
4. Agreeing to participate in the study

Exclusion Criteria

1. Patients had abnormal blood coagulation
2. Patients who cannot tolerate Cryo/Cuff
3. Patients were diagnosed as rheumatoid arthritis, traumatic osteoarthritis, ankylosing spondylitis, hemophilic arthritis, peripheral vascular disease
4. Cold urticaria
5. Preoperative anticoagulation, patients had preoperative deep vein thrombosis (DVT)
6. Preoperative history of anemia

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain is measured using the visual analogue scale (VAS) at rest and during exercise at baseline (1 day before surgery) and 1-5 days after surgery.

Secondary Outcome Measures

Name	Time	Method
1. Opioid consumption is measured by anesthesiologist at 72 hours removal of the sufentanil PCA pump<br>2. Swelling is measured using knee girth in millimeters at mid-patella with the knee in maximal extension at baseline (1 day before surgery) and 2 to 5 days after surgery<br>3. Wound drainage is assessed by the independent member of the research team at 48 hours<br>4. Hemoglobin is measured using blood test at admission, 1, 3 and 5 days after surgery<br>5. Blood transfusion rate is measured by the independent member of the research team at discharge<br>6. Range of motion is measured according to standard reference points (the greater throchanter, the lateral condyle of femur, and the later malleolus) with a goniometer in intervals of 1° and recorded as maximum active extension and flexion at baseline (one day before surgery), 1 and 2 weeks after surgery<br>7. Length of post-operative hospital stay is assessed by the independent member of the research team at patients’ discharge