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

A randomized controlled trial to evaluate whether Cryo/Cuff compared to placebo can better management of pain, swelling, blood loss, range of motion in postoperative total knee arthroplasty patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12615549

Enrollment

Registered

2017-04-10

Start date

2016-07-01

Completion date

Unknown

Last updated

2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative knee joint osteoarthritis Musculoskeletal Diseases Osteoarthritis

Interventions

Patients are randomised into either the Cryo/Cuff group or control group using computer-generated randomization sequence (SAS Statistical Software 9.1.3). Intervention group: Participants receive 3

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Opioid consumption is measured by anesthesiologist at 72 hours removal of the sufentanil PCA pump 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 3. Wound drainage is assessed by the independent member of the research team at 48 hours 4. Hemoglobin is measured using blood test at admission, 1, 3 and 5 days after surgery 5. Blood transfusion rate is measured by the independent member of the research team at discharge 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 7. Length of post-operative hospital stay is assessed by the independent member of the research team at patients’ discharge	—

Measure

Time frame

1. Opioid consumption is measured by anesthesiologist at 72 hours removal of the sufentanil PCA pump 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 3. Wound drainage is assessed by the independent member of the research team at 48 hours 4. Hemoglobin is measured using blood test at admission, 1, 3 and 5 days after surgery 5. Blood transfusion rate is measured by the independent member of the research team at discharge 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 7. Length of post-operative hospital stay is assessed by the independent member of the research team at patients’ discharge

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Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026