Neurectomy for Chronic Knee Pain

Overseen By Lori Chase, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

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

Compensation: Varies

Number of Visits: 1

178 Participants Needed

Trial Summary

What is the purpose of this 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.

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 data supports the effectiveness of the treatment Prophylactic Infrapatellar Saphenous Neurectomy for chronic knee pain?

Research shows that treating damage to the infrapatellar nerve, a branch of the saphenous nerve, can significantly reduce knee pain. In one study, a treatment plan including neurectomy (surgical removal of part of a nerve) led to a 73% success rate in reducing pain by more than half in patients with nerve damage. ^{1 2 3 4 5}

Is neurectomy for chronic knee pain generally safe for humans?

Neurectomy involving the infrapatellar branch of the saphenous nerve can lead to complications like numbness, skin reactions, and nerve injuries, especially during knee surgeries. However, some patients recover well and live normal lives after treatment, suggesting that while there are risks, the procedure can be safe with proper care. ^{6 7 8 9 10}

How is the treatment Prophylactic Infrapatellar Saphenous Neurectomy unique for chronic knee pain?

Prophylactic Infrapatellar Saphenous Neurectomy is unique because it involves surgically removing or cutting the infrapatellar branch of the saphenous nerve to relieve chronic knee pain, which is different from other treatments that may focus on nerve blocks or conservative management. This approach directly addresses nerve entrapment, a frequently overlooked cause of knee pain, by targeting the specific nerve branch responsible for the pain. ^{1 8 11 12 13}

Research Team

Glenn G Shi, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. Lebanon pubmed.ncbi.nlm.nih.gov

EFFECT OF ULTRASOUND-GUIDED SUBSARTORIAL APPROACH FOR SAPHENOUS NERVE BLOCK IN CASES WITH SAPHENOUS NERVE ENTRAPMENT IN ADDUCTOR CANAL FOR CONTROLLING CHRONIC KNEE PAIN. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Nonoperative treatment of recalcitrant neuritis of the infrapatellar saphenous nerve: a case series. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Infrapatellar nerve damage : A neglected cause of severe localized leg pain. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

[Infrapatellar nerve damage : A neglected cause of severe localized leg pain-German version]. [2020]

5. India pubmed.ncbi.nlm.nih.gov

Partial Denervation for Neuroma Pain after Knee Anterior Tibial Tuberosity Exostectomy: A Case Report. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

Fate of the infrapatellar branch of the saphenous nerve post total knee arthroplasty. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The surgical anatomy of the infrapatellar branch of the saphenous nerve in relation to incisions for anteromedial knee surgery. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Autonomic Denervation Dermatitis: A Relatively Undocumented 'ADD'itional Complication of Total Knee Replacements and Other Surgeries Around the Knee. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Effects of Leg Length, Sex, Laterality, and the Intermediate Femoral Cutaneous Nerve on Infrapatellar Innervation. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Surgical Treatment of Saphenous Nerve Injury Assisted by Plasma Rich in Growth Factors (PRGF): Lessons from a Case Report. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Surgical treatment outcome of painful traumatic neuroma of the infrapatellar branch of the saphenous nerve during total knee arthroplasty. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Neuropathy of the saphenous nerve as a cause of knee pain. [2005]

13. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided needle localization of the saphenous nerve for removal of neuroma in the infrapatellar branches: technical report. [2018]