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

Not Applicable

Active, not recruiting

• Conditions: Knee Arthroplasty, Total; Rehabilitation Therapy

• Registration Number: NCT07089212
• Lead Sponsor: Qilu Hospital of Shandong University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-23
• Primary Completion: 2025-05-29
• Status Verified: 2025-07
• Study First Submitted: 2025-07-20
• Study First Submitted QC: 2025-07-20
• Last Update Submitted: 2025-07-20
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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).

  2. 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).

  3. 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Knee Function Scores	At 6 weeks after completion of treatment.

Secondary Outcome Measures

Name	Time	Method
Range of Motion (ROM)	At 6 weeks after completion of treatment.
Muscle Strength	At 6 weeks after completion of treatment.
Activities of Daily Living (ADLs)	At 6 weeks after completion of treatment.
Visual Analog Scale (VAS)	At 6 weeks after completion of treatment.

Trial Locations

Locations (1)

107 Wenhua Xi Road, Ji'nan Shandong 250012; 🇨🇳 Jinan, Shandong, China