Knee Arthroplasty, TotalNCT07089212
Combined Cyclic Compression Cryotherapy and Phased Rehabilitation Training for Recovery After Knee Replacement
A study testing Phased Rehabilitation Training, Cyclic Compression Cryotherapy and Conventional rehabilitation treatment. in people with Knee Arthroplasty, Total and Rehabilitation Therapy, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Arthroplasty, Total, Rehabilitation Therapy
- What is being tested?
- Phased Rehabilitation Training, Cyclic Compression Cryotherapy and Conventional rehabilitation treatment.
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- No contraindications for surgery or postoperative rehabilitation.
- Intact cognitive function (able to provide informed consent and follow instructions).
- Available for all follow-up evaluations.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Cyclic Compression Cryotherapy Combined With Phased Rehabilitation Training on Lower Limb Functional Recovery in Patients After Total Knee Arthroplasty
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.
- Conditions
- Knee Arthroplasty, Total, Rehabilitation Therapy
- Being tested
- Phased Rehabilitation Training, Cyclic Compression Cryotherapy, Conventional rehabilitation treatment.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phased Rehabilitation TrainingBehavioural
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 CryotherapyDevice
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.Behavioural
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 group | Role | What they receive |
|---|---|---|
| conventional rehabilitation treatment. | Active comparator | 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). Receives: Behavioral: Conventional rehabilitation treatment. |
| Cyclic cryotherapy combined with staged rehabilitation treatment. | Experimental | The experimental group received cyclic compression cryotherapy combined with phased rehabilitation training in addition to the conventional rehabilitation program, with a total intervention duration of 12 weeks. Receives: Behavioral: Phased Rehabilitation Training; Device: Cyclic Compression Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Function Scores
Measured: At 6 weeks after completion of treatment.
Secondary outcomes (4)
Range of Motion (ROM)
Measured: At 6 weeks after completion of treatment.
Muscle Strength
Measured: At 6 weeks after completion of treatment.
Activities of Daily Living (ADLs)
Measured: At 6 weeks after completion of treatment.
Visual Analog Scale (VAS)
Measured: At 6 weeks after completion of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start23 Apr 2025
- Primary completion29 May 2025
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089212
- Sponsor's protocol ID
- KYLL-202502-012-1
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Cyclic Compression Cryotherapy Combined With Phased Rehabilitation Training on Lower Limb Functional Recovery in Patients After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07089212
- Acronym / sponsor ID
- KYLL-202502-012-1
- Conditions
- Knee Arthroplasty, Total, Rehabilitation Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional rehabilitation treatment. | Active comparator | Behavioral: 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). |
| Cyclic cryotherapy combined with staged rehabilitation treatment. | Experimental | Behavioral: Phased Rehabilitation Training, Device: Cyclic Compression CryotherapyThe experimental group received cyclic compression cryotherapy combined with phased rehabilitation training in addition to the conventional rehabilitation program, with a total intervention duration of 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phased Rehabilitation TrainingRehabilitation 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. | Behavioural | Cyclic cryotherapy combined with staged rehabilitation treatment. |
| Cyclic Compression CryotherapyInitiation: 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. | Device | Cyclic cryotherapy combined with staged rehabilitation treatment. |
| 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). | Behavioural | conventional rehabilitation treatment. |
Primary outcome
Knee Function Scores
Time frame: At 6 weeks after completion of treatment.
4 secondary outcomes
Range of Motion (ROM)
Time frame: At 6 weeks after completion of treatment.
Muscle Strength
Time frame: At 6 weeks after completion of treatment.
Activities of Daily Living (ADLs)
Time frame: At 6 weeks after completion of treatment.
Visual Analog Scale (VAS)
Time frame: At 6 weeks after completion of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phased Rehabilitation Training, Cyclic Compression Cryotherapy and Conventional rehabilitation treatment. in people with Knee Arthroplasty, Total and Rehabilitation Therapy, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Function Scores (time frame: At 6 weeks after completion of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.