Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07089212

Combined Cyclic Compression Cryotherapy and Phased Rehabilitation Training for Recovery After Knee Replacement

Total knee arthroplasty (TKA) is an effective treatment for severe knee joint diseases; however, postoperative complications such as pain, swelling, and delayed functional recovery remain common challenges. Cyclic compression cryotherapy, which applies alternating cold and pressure to the knee joint, can effectively reduce swelling and alleviate pain. Meanwhile, phased rehabilitation training, tailored to the specific recovery stages post-surgery, facilitates targeted exercise interventions to promote functional restoration of the knee joint.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Knee Arthroplasty, Total Rehabilitation Therapy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

107 Wenhua Xi Road, Ji'nan Shandong 250012

Jinan, Shandong, 250012, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with knee osteoarthritis (KOA) and within 12 weeks after total knee arthroplasty (TKA).
  • Aged 18-70 years.
  • First-time unilateral TKA (non-revision surgery).
  • Physically and cognitively capable of completing required assessments.
  • Able to fully adhere to the study protocol.
  • Willing to participate in and complete the entire rehabilitation program.
  • No contraindications for surgery or postoperative rehabilitation.
  • Intact cognitive function (able to provide informed consent and follow instructions).
  • Available for all follow-up evaluations.

Exclusion criteria

  • 1. Severe cardiovascular or cerebrovascular diseases. 2. Neuromuscular impairments affecting the lower limbs. 3. Concurrent hip or ankle joint disorders. 4. Intolerance to pain (unable to tolerate rehabilitation protocols). 5. Primary or metastatic bone tumors. 6. Rheumatoid arthritis (RA) or other systemic inflammatory arthropathies. 7. Severe obesity (BMI ≥35) or malnutrition (clinically diagnosed). 8. Inability to comply with study assessments (e.g., due to cognitive or physical limitations).
  • Visual dysfunction impairing task performance. 10. Functional impairment of the non-operated limb hindering testing/training. 11. Ankylosing spondylitis (AS). 12. History of allergic hypersensitivity to interventions used in the study. 13. Hemorrhagic predisposition (e.g., coagulation disorders, anticoagulant use).
  • Active tuberculosis or chronic myelitis. 15. History of substance dependence (e.g., opioids, alcohol). 16. Psychiatric disorders (e.g., schizophrenia, major depression). 17. Severe dysfunction of major organs (e.g., hepatic, renal, pulmonary).

Treatment and study plan

Phased Rehabilitation Training

Behavioral

Rehabilitation is divided into three postoperative phases:

Early Phase (Weeks 1-2): Focus on edema control, quadriceps activation, and passive/active-assisted range of motion (ROM) exercises.

Intermediate Phase (Weeks 3-6): Progress to strength training, endurance exercises, and early proprioception drills.

Late Phase (Weeks 7-12): Advance to functional training , dynamic proprioception, and full ROM restoration.

Cyclic Compression Cryotherapy

Device

Initiation: Begin within 24 hours postoperatively. Each session lasts 20-30 minutes, administered 2-3 times daily.

Procedure: Apply a cryotherapy wrap circumferentially around the knee using a pneumatic compression device, with precise control of pressure and temperature.

Pressure Settings: Start at Level I-II (low-to-moderate) and adjust incrementally based on patient tolerance.

Temperature Control: Maintain at 10-12°C.

Conventional rehabilitation treatment.

Behavioral

The control group underwent a 12-week conventional rehabilitation program, which primarily included muscle strength training, endurance training, proprioception training, and joint range of motion (ROM) exercises. Assessments were conducted at baseline (before treatment), as well as at 2 weeks, 6 weeks, and 12 weeks post-treatment. The evaluated outcomes included knee joint ROM, muscle strength, knee function, pain levels, and activities of daily living (ADL).

Primary outcomes

  1. Knee Function Scores

    Time frame: At 6 weeks after completion of treatment.

Secondary outcomes

  1. Range of Motion (ROM)

    Time frame: At 6 weeks after completion of treatment.

  2. Muscle Strength

    Time frame: At 6 weeks after completion of treatment.

  3. Activities of Daily Living (ADLs)

    Time frame: At 6 weeks after completion of treatment.

  4. Visual Analog Scale (VAS)

    Time frame: At 6 weeks after completion of treatment.

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

The Efficacy of Cyclic Compression Cryotherapy Combined With Phased Rehabilitation Training on Lower Limb Functional Recovery in Patients After Total Knee Arthroplasty

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.