Knee Pain ChronicNCT04028947
Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty
A study testing Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty in people with Knee Pain Chronic, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to determine if knee pain can be reduced by proactively protecting the free end of the saphenous nerve versus leaving it in the standard position during total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Knee Pain Chronic
- What is being tested?
- Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2020to Dec 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary unilateral total knee arthroplasty candidate
Who cannot join
- Body Mass Index (BMI) >40
- Inflammatory arthritis
- Unable to follow up visits (long distance from Mayo Clinic)
- Poor compliance risk
- Health condition deemed by physician to preclude patient's ability to participate in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty: A Double-Blind Randomized Controlled Trial
Researchers are trying to determine if knee pain can be reduced by proactively protecting the free end of the saphenous nerve versus leaving it in the standard position during total knee arthroplasty.
Read the detailed description
Subjects scheduled for total knee arthroplasty will be randomized to two arms. One arm will have the standard saphenous nerve neurectomy during their surgery. The other arm will have the same neurectomy procedure with the free end of the nerve tucked into soft tissue to protect the nerve ending.
- Conditions
- Knee Pain Chronic
- Being tested
- Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee ArthroplastyProcedure or surgery
Prophylactic infrapatellar saphenous nerve neurectomy will be performed at the same time as the TKA.
| Study group | Role | What they receive |
|---|---|---|
| Standard TKA | No intervention | Subjects will have the standard procedure. |
| TKA with Neurectomy | Active comparator | Subjects will the nerve excised and protected with soft tissue. Receives: Procedure: Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain after surgery
Self-reported pain using Visual Analog Scale which is scored using a horizontal scale from 0-10cm with 10 being the worst pain.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start28 Jan 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Pain ChronicStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenn G. Shi, M.D., Mayo Clinic
- Investigators
- Glenn G Shi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028947
- Sponsor's protocol ID
- 19-000527
- Status last verified
- Jan 2026
- First submitted
- 27 Mar 2019
- Last updated
- 14 Jan 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 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04028947
- Acronym / sponsor ID
- 19-000527
- Conditions
- Knee Pain Chronic
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Jul 2019 (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.
Researchers are trying to determine if knee pain can be reduced by proactively protecting the free end of the saphenous nerve versus leaving it in the standard position during total knee arthroplasty.
Detailed description
Subjects scheduled for total knee arthroplasty will be randomized to two arms. One arm will have the standard saphenous nerve neurectomy during their surgery. The other arm will have the same neurectomy procedure with the free end of the nerve tucked into soft tissue to protect the nerve ending.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard TKA | No intervention | –Subjects will have the standard procedure. |
| TKA with Neurectomy | Active comparator | Procedure: Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee ArthroplastySubjects will the nerve excised and protected with soft tissue. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary unilateral total knee arthroplasty candidate
Key exclusion criteria (5 listed)
- Body Mass Index (BMI) >40
- Inflammatory arthritis
- Unable to follow up visits (long distance from Mayo Clinic)
- Poor compliance risk
- Health condition deemed by physician to preclude patient's ability to participate in the trial
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 |
|---|---|---|
| Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee ArthroplastyProphylactic infrapatellar saphenous nerve neurectomy will be performed at the same time as the TKA. | Procedure or surgery | TKA with Neurectomy |
Primary outcome
Pain after surgery
Time frame: 6 months
Self-reported pain using Visual Analog Scale which is scored using a horizontal scale from 0-10cm with 10 being the worst pain.
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 14 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Glenn G Shi, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty in people with Knee Pain Chronic, run by Mayo Clinic at 1 site in United States.
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 1 inclusion and 5 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 14 Jan 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 United States. 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?
Pain after surgery (time frame: 6 months). 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 14 Jan 2026.