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Clinical Trials in China / NCT07089212
Active, not recruiting Not applicable

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

NCT07089212 · tracked via the Priya Life Science China tracker
Sponsor
Qilu Hospital of Shandong University
Phase
Not applicable
Started
2025-04-23
Last updated
2025-07-28

Condition(s) studied

Knee Arthroplasty, TotalRehabilitation Therapy

Investigational drug(s) / intervention(s)

Phased Rehabilitation TrainingCyclic Compression CryotherapyConventional rehabilitation treatment.

Phased Rehabilitation Training: 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: 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.: 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).

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Diagnosed with knee osteoarthritis (KOA) and within 12 weeks after total knee arthroplasty (TKA). 2. Aged 18-70 years. 3. First-time unilateral TKA (non-revision surgery). 4. Physically and cognitively capable of completing required assessments. 5. Able to fully adhere to the study protocol. 6. Willing to participate in and complete the entire rehabilitation program. 7. No contraindications for surgery or postoperative rehabilitation. 8. Intact cognitive function (able to provide informed consent and follow instructions). 9. 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). 9\. 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). 14\. 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).

Primary outcome measure(s)

  • Knee Function Scores — At 6 weeks after completion of treatment.

Trial sites (1)

FacilityCityRegionStatus
107 Wenhua Xi Road, Ji'nan Shandong 250012 Jinan Shandong

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Other trials for the same condition

Factor XI inhibiTion for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07089212 on ClinicalTrials.gov ↗ ← All trials in China