Neurectomy for Chronic Knee Pain

Overseen By Lori Chase, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Bmi >40, Inflammatory arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to reduce chronic knee pain during knee replacement surgery. Researchers aim to determine if protecting the saphenous nerve can lessen pain compared to the standard procedure. Participants will either receive a special technique called Prophylactic Infrapatellar Saphenous Neurectomy or undergo the usual surgery. The trial seeks individuals scheduled for knee replacement on one knee who do not have inflammatory arthritis or a BMI over 40. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this neurectomy technique is safe for reducing knee pain?

Research has shown that the safety of Prophylactic Infrapatellar Saphenous Neurectomy, which involves removing and protecting a nerve during knee surgery, is still under investigation. One study found that 67% of patients responded positively to a nerve block test, suggesting the procedure might reduce knee pain. However, 33% did not respond, indicating variability.

Since this trial is in its early stages, detailed safety information remains limited. Early-phase trials typically assess how well participants tolerate a treatment. Advancing to later stages often indicates an initial reasonable level of safety.

This procedure is compared to standard knee surgery methods. While the general safety of knee surgery is well understood, the focus here is on testing the safety and effectiveness of the additional nerve procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about prophylactic infrapatellar saphenous neurectomy for chronic knee pain because it offers a novel approach compared to traditional treatments like standard total knee arthroplasty (TKA). Unlike typical procedures that focus on joint replacement, this technique involves removing a specific nerve to directly target and reduce pain. By excising and protecting the nerve with soft tissue, the method aims to provide more targeted pain relief and potentially enhance recovery after knee surgery. This innovative approach could significantly improve outcomes for patients suffering from persistent knee pain.

What evidence suggests that prophylactic infrapatellar saphenous neurectomy is effective for reducing chronic knee pain?

Research has shown that targeting a specific nerve near the knee, the infrapatellar branch of the saphenous nerve, can significantly aid in pain relief for individuals with knee issues. Studies have found that this approach can also lessen the need for painkillers like opioids after surgery. One series of cases suggested that removing this nerve might decrease long-term knee pain and boost patient satisfaction. In this trial, participants will undergo either a standard total knee arthroplasty (TKA) or TKA with the neurectomy procedure. Specifically, those who had surgery on this nerve reported a 95% improvement in symptoms such as pain, numbness, and weakness. These findings suggest that removing this nerve during knee surgery could effectively reduce ongoing knee pain. ^{1 6 7 8 9}

Who Is on the Research Team?

Glenn G Shi, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals who are candidates for a primary unilateral total knee arthroplasty due to chronic knee pain. Participants should not have a BMI over 40, inflammatory arthritis, health conditions that interfere with the trial, or be at risk of poor compliance. They must be able to attend follow-up visits at Mayo Clinic.

Inclusion Criteria

You are planning to undergo surgery to replace your entire knee joint on one side of your body.

Exclusion Criteria

You have a BMI above 40, indicating severe obesity.

Poor compliance risk

Health condition deemed by physician to preclude patient's ability to participate in the trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Subjects undergo total knee arthroplasty with either standard saphenous nerve neurectomy or neurectomy with nerve end protection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain and recovery after surgery

6 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Prophylactic Infrapatellar Saphenous Neurectomy

Trial Overview The study is examining if protecting the saphenous nerve by performing an infrapatellar neurectomy during knee replacement surgery can reduce postoperative knee pain compared to leaving the nerve in its standard position.

How Is the Trial Designed?

Group I: TKA with Neurectomy Active Control 1 Intervention

Subjects will the nerve excised and protected with soft tissue.

Group II: Standard TKA Active Control 1 Intervention

Subjects will have the standard procedure.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04028947

Prophylactic Infrapatellar Saphenous Neurectomy in ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11962285/

Targeting the Infrapatellar Branch of the Saphenous Nerve ... The results indicated that the IPBSN block significantly improved pain relief and reduced opioid consumption in patients with acute postoperative or chronic ...

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/10225536221127460

A retrospective case series of prophylactic neurectomy ... We hypothesized that prophylactic neurectomy would reduce the rate of chronic knee pain and increase patient satisfaction following surgery.

4. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-09099-5

Application of saphenous nerve infrapatellar branch protection ... This randomized controlled trial conducted a comparative analysis of postoperative outcomes between a modified anteromedial incision with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12142898/

Surgical management of peripheral nerve symptoms ... In patients with neuropathic pain, numbness, or weakness after KA, peripheral nerve surgery may be beneficial, with 95% of patients reporting ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8330472/

Diagnostics of infrapatellar saphenous neuralgia—a ... Sixty-seven percent (37/55) responded positively to the diagnostic nerve block, while 33% (18/55) did not respond. Responders and non-responders ...

7. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04028947?keyword=%22Knee%20Pain%22

San Mateo Clinical Trial Prophylactic Infrapatellar ... Subjects scheduled for total knee arthroplasty will be randomized to two arms. One arm will have the standard saphenous nerve neurectomy during their ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0976566218300924

Case report Cadaveric study of the infrapatellar branch of ... Total knee arthroplasty (TKA) is commonly used to treat end-stage arthritis, but the IPBSN is often injured and results in numbness around the anteromedial knee ...

9. researchgate.net researchgate.net/publication/377848816_Infrapatellar_Branch_of_the_Saphenous_Nerve_Therapeutic_Approaches_to_Chronic_Knee_Pain

Infrapatellar Branch of the Saphenous Nerve: Therapeutic ... This review aims to evaluate the etiologies and therapeutic approaches for chronic pain arising from the IPS refractory to conservative treatments.