Recovery After Total Knee ArthroplastyNCT07926204
Functional Massage Versus Passive Mobilization After Total Knee Replacement
A study testing Functional Massage According to Olaf Evjenth and Passive Manual Knee Mobilization in people with Recovery After Total Knee Arthroplasty, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
This study compares two physiotherapy treatments to help adults recover movement after total knee replacement: functional massage and passive knee mobilization. The main question is whether functional massage helps patients bend their knee further by the time they leave the acute hospital ward. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Recovery After Total Knee Arthroplasty
- What is being tested?
- Functional Massage According to Olaf Evjenth and Passive Manual Knee Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 24 Nov 2026to Aug 2028
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 18 to 79 years.
- Scheduled for elective primary total knee arthroplasty, either unilateral or simultaneous bilateral.
- Ability to understand the nature of the study and provide written informed consent.
Who cannot join
- Revision total knee arthroplasty.
- Age 80 years or older.
- Severe comorbidities that could interfere with participation in the rehabilitation protocol or outcome assessment, including severe heart failure, severe chronic obstructive pulmonary disease, severe obesity with body mass index greater than 40 kg/m², or neurological conditions with significant motor deficits.
- Cognitive deficits that prevent understanding and signing the informed consent or active participation in rehabilitation.
- Total knee arthroplasty performed for non-degenerative causes, such as acute trauma or tumors.
- Concomitant participation in another interventional clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Azienda Ospedaliera Universitaria Integrata Verona - U.O.C. Ortopedia, Ospedale Chirurgico Confortini
Verona, Verona, 37126
Simone Patuzzo, +393408117670, simone.patuzzo@aovr.veneto.it
Daniela Isolani, 00390458122480, daniela.isolani@intra.aovr.veneto.it
About this study
Official title: Functional Recovery in the Acute Phase After Total Knee Arthroplasty: A Randomized Controlled Trial Comparing Two Different Physiotherapy Protocols
This study compares two physiotherapy treatments to help adults recover movement after total knee replacement: functional massage and passive knee mobilization. The main question is whether functional massage helps patients bend their knee further by the time they leave the acute hospital ward.
Forty adults undergoing replacement of one knee or both knees during the same operation will be randomly assigned to one of two groups. One group will receive functional massage according to Olaf Evjenth, and the other will receive passive manual knee mobilization. Both groups will also receive the same standard rehabilitation and pain management.
Read more
The assigned treatment will be provided once daily, starting on the first day after surgery and continuing until hospital discharge. Each treatment will last 10 minutes per operated knee.
A clinician who does not know which treatment the patient received will assess knee movement. The study will also evaluate pain, functional mobility, patient-reported outcomes, and length of hospital stay.
Read the detailed description
This is a single-center, randomized, parallel-group superiority trial comparing two manual physiotherapy approaches during the acute phase after total knee arthroplasty.
An independent researcher will generate the random allocation sequence. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes, opened after eligibility has been confirmed and written informed consent obtained.
The primary analysis will follow the intention-to-treat principle. Passive knee flexion at discharge will be compared between groups using analysis of covariance, with baseline knee flexion as a covariate. For participants undergoing simultaneous bilateral total knee arthroplasty, one knee will be randomly selected for the primary analysis. A sensitivity analysis using mixed-effects models will account for paired knee measurements. Exploratory analyses will compare treatment effects in participants undergoing unilateral and simultaneous bilateral surgery.
Discharge timing depends on the availability of a bed in an inpatient rehabilitation facility rather than on predefined functional recovery thresholds.
- Conditions
- Recovery After Total Knee Arthroplasty
- Being tested
- Functional Massage According to Olaf Evjenth, Passive Manual Knee Mobilization
- Keywords
- Total Knee Arthroplasty, Physiotherapy, Functional Massage, Passive Mobilization, Postoperative Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Massage According to Olaf EvjenthOther
Functional massage of the anterior thigh with passive or active-assisted knee flexion, performed with the patient seated. Treatment lasts 10 minutes per operated knee, once daily, from postoperative day 1 until hospital discharge.
Passive Manual Knee MobilizationOther
Passive manual knee flexion and extension in the sagittal plane, performed with the patient supine. Treatment lasts 10 minutes per operated knee, once daily, from postoperative day 1 until hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| Functional Massage | Experimental | Participants receive functional massage according to Olaf Evjenth once daily from postoperative day 1 until hospital discharge, together with standardized pain management, assisted walking, and strengthening exercises. Receives: Other: Functional Massage According to Olaf Evjenth |
| Passive Manual Mobilization | Active comparator | Participants receive passive manual knee mobilization once daily from postoperative day 1 until hospital discharge, together with standardized pain management, assisted walking, and strengthening exercises. Receives: Other: Passive Manual Knee Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Flexion
Passive knee flexion is measured in degrees using a standard goniometer, with the assessor moving the knee. Measurements are collected daily from postoperative day 1 until hospital discharge
Measured: Daily from postoperative day 1 until hospital discharge, typically 5-7 days after surgery.
Secondary outcomes (15)
Pain Intensity
Pain intensity is assessed using a Visual Analogue Scale and recorded on a 0-10 scale, with higher scores indicating greater pain. Measurements are collected at baseline and daily after each rehabilitation session from postoperative day 1 until hospital discharge, including the discharge day. Each daily measurement is recorded separately.
Measured: At baseline and daily from postoperative day 1 until hospital discharge, typically 5-7 days after surgery.
Timed Up and Go Test
Time in seconds required to stand up, walk 3 meters, turn, walk back, and sit down. The test is performed daily after the rehabilitation session from postoperative day 1 until hospital discharge, including the discharge day. Shorter times indicate better functional mobility. Each daily measurement is recorded separately.
Measured: Daily from postoperative day 1 until hospital discharge, typically 5-7 days after surgery.
Length of Hospital Stay
Number of days from admission to the acute hospital ward until discharge
Measured: At discharge from the acute hospital ward, typically 5-7 days after surgery.
Oxford Knee Score on Postoperative Day 1
The Oxford Knee Score is a 12-item questionnaire assessing knee pain and difficulties with everyday activities over the previous four weeks. Each item is scored from 0 to 4. The total score ranges from 0 to 48, with higher scores indicating less pain and better function.
Measured: Postoperative day 1.
Oxford Knee Score at Hospital Discharge
The Oxford Knee Score is a 12-item questionnaire assessing knee pain and difficulties with everyday activities over the previous four weeks. Each item is scored from 0 to 4. The total score ranges from 0 to 48, with higher scores indicating less pain and better function.
Measured: At discharge from the acute hospital ward, typically 5-7 days after surgery.
Oxford Knee Score at 1 Month
The Oxford Knee Score is a 12-item questionnaire assessing knee pain and difficulties with everyday activities over the previous four weeks. Each item is scored from 0 to 4. The total score ranges from 0 to 48, with higher scores indicating less pain and better function. The questionnaire is administered by telephone interview.
Measured: 1 month after surgery
Oxford Knee Score at 3 Months
The Oxford Knee Score is a 12-item questionnaire assessing knee pain and difficulties with everyday activities over the previous four weeks. Each item is scored from 0 to 4. The total score ranges from 0 to 48, with higher scores indicating less pain and better function. The questionnaire is administered by telephone interview.
Measured: 3 months after surgery
EQ-5D-5L Utility Index at day 1
The EQ-5D-5L assesses five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, from no problems to extreme problems or inability to perform the activity. Responses are converted into a health utility index using a country-specific value set. Higher index values indicate better health-related quality of life
Measured: Postoperative day 1.
EQ-5D-5L Utility Index at discharge
The EQ-5D-5L assesses five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, from no problems to extreme problems or inability to perform the activity. Responses are converted into a health utility index using a country-specific value set. Higher index values indicate better health-related quality of life.
Measured: At discharge from the acute hospital ward, typically 5-7 days after surgery.
EQ-5D-5L Utility Index at 1 Month
The EQ-5D-5L assesses five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, from no problems to extreme problems or inability to perform the activity. Responses are converted into a health utility index using a country-specific value set. Higher index values indicate better health-related quality of life. The questionnaire is administered by telephone
Measured: 1 month after surgery
EQ-5D-5L Utility Index at 3 Months
The EQ-5D-5L assesses five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, from no problems to extreme problems or inability to perform the activity. Responses are converted into a health utility index using a country-specific value set. Higher index values indicate better health-related quality of life. The questionnaire is administered by telephone
Measured: 3 months after surgery
EQ VAS on Postoperative Day 1
Participants rate their overall health today on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine). Higher scores indicate better self-rated health.
Measured: On postoperative day 1.
EQ VAS at Hospital Discharge
Participants rate their overall health today on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine). Higher scores indicate better self-rated health.
Measured: At hospital discharge, typically 5-7 days after surgery.
EQ VAS at 1 Month
Participants rate their overall health today on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine). Higher scores indicate better self-rated health.The assessment is administered by telephone
Measured: At 1 month after surgery.
EQ VAS at 3 Months
Participants rate their overall health today on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine). Higher scores indicate better self-rated health. The assessment is administered by telephone
Measured: At 3 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start24 Nov 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recovery After Total Knee ArthroplastyStudies of the same condition, open and under way.
- 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
- Model description
- Single-center, two-arm superiority trial with participants randomized in a 1:1 ratio to functional massage or passive manual knee mobilization.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone Patuzzo, Principal investigator, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07926204
- Sponsor's protocol ID
- TKA-PATUZZO-2025-01
- Other IDs
- 1000CET
- Status last verified
- Nov 2026
- First submitted
- 3 Nov 2026
- Last updated
- 9 Nov 2026
- 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 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Recovery in the Acute Phase After Total Knee Arthroplasty: A Randomized Controlled Trial Comparing Two Different Physiotherapy Protocols
- ClinicalTrials.gov ID
- NCT07926204
- Acronym / sponsor ID
- TKA-PATUZZO-2025-01
- Conditions
- Recovery After Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, Physiotherapy, Functional Massage, Passive Mobilization, Postoperative Rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 24 Nov 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 9 Nov 2026 (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.
This study compares two physiotherapy treatments to help adults recover movement after total knee replacement: functional massage and passive knee mobilization. The main question is whether functional massage helps patients bend their knee further by the time they leave the acute hospital ward.
Forty adults undergoing replacement of one knee or both knees during the same operation will be randomly assigned to one of two groups. One group will receive functional massage according to Olaf Evjenth, and the other will receive passive manual knee mobilization. Both groups will also receive the same standard rehabilitation and pain management.
The assigned treatment will be provided once daily, starting on the first day after surgery and continuing until hospital discharge. Each treatment will last 10 minutes per operated knee.
A clinician who does not know which treatment the patient received will assess knee movement. The study will also evaluate pain, functional mobility, patient-reported outcomes, and length of hospital stay.
Detailed description
This is a single-center, randomized, parallel-group superiority trial comparing two manual physiotherapy approaches during the acute phase after total knee arthroplasty.
An independent researcher will generate the random allocation sequence. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes, opened after eligibility has been confirmed and written informed consent obtained.
The primary analysis will follow the intention-to-treat principle. Passive knee flexion at discharge will be compared between groups using analysis of covariance, with baseline knee flexion as a covariate. For participants undergoing simultaneous bilateral total knee arthroplasty, one knee will be randomly selected for the primary analysis. A sensitivity analysis using mixed-effects models will account for paired knee measurements. Exploratory analyses will compare treatment effects in participants undergoing unilateral and simultaneous bilateral surgery.
Discharge timing depends on the availability of a bed in an inpatient rehabilitation facility rather than on predefined functional recovery thresholds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center, two-arm superiority trial with participants randomized in a 1:1 ratio to functional massage or passive manual knee mobilization.
| Arm | Type | Receives |
|---|---|---|
| Functional Massage | Experimental | Other: Functional Massage According to Olaf EvjenthParticipants receive functional massage according to Olaf Evjenth once daily from postoperative day 1 until hospital discharge, together with standardized pain management, assisted walking, and strengthening exercises. |
| Passive Manual Mobilization | Active comparator | Other: Passive Manual Knee MobilizationParticipants receive passive manual knee mobilization once daily from postoperative day 1 until hospital discharge, together with standardized pain management, assisted walking, and strengthening exercises. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients aged 18 to 79 years.
- Scheduled for elective primary total knee arthroplasty, either unilateral or simultaneous bilateral.
- Ability to understand the nature of the study and provide written informed consent.
Key exclusion criteria (6 listed)
- Revision total knee arthroplasty.
- Age 80 years or older.
- Severe comorbidities that could interfere with participation in the rehabilitation protocol or outcome assessment, including severe heart failure, severe chronic obstructive pulmonary disease, severe obesity with body mass index greater than 40 kg/m², or neurological conditions with significant motor deficits.
- Cognitive deficits that prevent understanding and signing the informed consent or active participation in rehabilitation.
- Total knee arthroplasty performed for non-degenerative causes, such as acute trauma or tumors.
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 |
|---|---|---|
| Functional Massage According to Olaf EvjenthFunctional massage of the anterior thigh with passive or active-assisted knee flexion, performed with the patient seated. Treatment lasts 10 minutes per operated knee, once daily, from postoperative day 1 until hospital discharge. | Other | Functional Massage |
| Passive Manual Knee MobilizationPassive manual knee flexion and extension in the sagittal plane, performed with the patient supine. Treatment lasts 10 minutes per operated knee, once daily, from postoperative day 1 until hospital discharge. | Other | Passive Manual Mobilization |
Primary outcome
Knee Flexion
Time frame: Daily from postoperative day 1 until hospital discharge, typically 5-7 days after surgery.
Passive knee flexion is measured in degrees using a standard goniometer, with the assessor moving the knee. Measurements are collected daily from postoperative day 1 until hospital discharge
15 secondary outcomes
Pain Intensity
Time frame: At baseline and daily from postoperative day 1 until hospital discharge, typically 5-7 days after surgery.
Timed Up and Go Test
Time frame: Daily from postoperative day 1 until hospital discharge, typically 5-7 days after surgery.
Length of Hospital Stay
Time frame: At discharge from the acute hospital ward, typically 5-7 days after surgery.
Oxford Knee Score on Postoperative Day 1
Time frame: Postoperative day 1.
Oxford Knee Score at Hospital Discharge
Time frame: At discharge from the acute hospital ward, typically 5-7 days after surgery.
Oxford Knee Score at 1 Month
Time frame: 1 month after surgery
Oxford Knee Score at 3 Months
Time frame: 3 months after surgery
EQ-5D-5L Utility Index at day 1
Time frame: Postoperative day 1.
EQ-5D-5L Utility Index at discharge
Time frame: At discharge from the acute hospital ward, typically 5-7 days after surgery.
EQ-5D-5L Utility Index at 1 Month
Time frame: 1 month after surgery
EQ-5D-5L Utility Index at 3 Months
Time frame: 3 months after surgery
EQ VAS on Postoperative Day 1
Time frame: On postoperative day 1.
EQ VAS at Hospital Discharge
Time frame: At hospital discharge, typically 5-7 days after surgery.
EQ VAS at 1 Month
Time frame: At 1 month after surgery.
EQ VAS at 3 Months
Time frame: At 3 months after surgery.
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 9 Nov 2026.
- Individual participant dataSharing planned: No
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The restor3d Outcomes Registry
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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.
Simone Patuzzo principal investigator
Azienda Ospedaliera Universitaria Integrata Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Massage According to Olaf Evjenth and Passive Manual Knee Mobilization in people with Recovery After Total Knee Arthroplasty, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 9 Nov 2026. 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 Italy. 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?
Contact Simone Patuzzo, Physiotherapist (+393408117670, simone.patuzzo@aovr.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Flexion (time frame: Daily from postoperative day 1 until hospital discharge, typically 5-7 days after surgery.). 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 9 Nov 2026.