NeuralgiaNCT02885467
Nerve Burial for Preventing Neuralgia After Total Knee Arthroplasty
A study testing Total knee arthroplasty with Saphenous nerve burial and Standard total knee arthroplasty in people with Neuralgia and Osteoarthritis of the Knee, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
This is a randomized study investigating whether identification, ligation, and burial of superficial branches of the saphenous nerve crossing the surgical field during total knee arthroplasty reduces the rate of post-operative anterior knee pain and neuralgia compared to standard total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuralgia, Osteoarthritis of the Knee
- What is being tested?
- Total knee arthroplasty with Saphenous nerve burial and Standard total knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have symptomatic knee osteoarthritis under consideration for total knee arthroplasty
- Must be willing to undergo randomization
Who cannot join
- Age <18 or >80 years
- Known pre-operative diagnosis of neuralgia, complex regional pain syndrome, or neuropathy, about the operative lower extremity
- Known pre-operative psychiatric disorder requiring medication
- Previous surgery about the operative knee
- BMI > 40 kg/m2 (potential increased risk of soft tissue dissection through adipose)
- Ongoing pre-operative narcotic use in excess of 20 mg morphine equivalents per day for at least one month or pre-operative intravenous drug use (increased potential for complex regional pain syndrome and neuralgia, increased likelihood to require greater post-operative analgesia)
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- Ongoing pre-operative use of neuropathic pain medications (gabapentin, pregabalin, amitriptyline, etc.)
- Medical comorbidities (American Society of Anesthesiologists grade > 3 or deemed unfit by consulting internist) precluding elective TKA
- Significant language barrier (reading comprehension less than 8th grade reading level) or mental condition precluding accurate self-assessment of knee pain or function.
- Severe medication allergies to permissible post-operative analgesics (acetaminophen, tramadol, oxycodone, oxycontin, dilaudid)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medstar Union Memorial Hospital
Baltimore, Maryland, 21218
About this study
Official title: Saphenous Nerve Brach Burial for Preventing Neuralgia After Total Knee Arthroplasty: A Randomized Controlled Trial
This is a randomized study investigating whether identification, ligation, and burial of superficial branches of the saphenous nerve crossing the surgical field during total knee arthroplasty reduces the rate of post-operative anterior knee pain and neuralgia compared to standard total knee arthroplasty.
Read the detailed description
Anterior knee pain is common after total knee arthroplasty. The incision necessarily travels through the path of a cutaneous nerve - branches of the saphenous nerve. Historically, no effort has been made to separate these branches and bury them away from the surgical scar. It has been noted that some patients develop a painful neuroma, that once resected results in a pain free knee. Investigators are trying to study if identification, ligation, and proper burial of the nerve can prevent the development of neuralgia compared to the typical surgical approach which ignores the nerve branches completely.
- Conditions
- Neuralgia, Osteoarthritis of the Knee
- Being tested
- Total knee arthroplasty with Saphenous nerve burial, Standard total knee arthroplasty
- Keywords
- Total Knee Arthroplasty
- Medical subject headings
- Neuralgia, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplasty with Saphenous nerve burialProcedure or surgery
Standard total knee arthroplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard total knee arthroplasty performed through medial parapatellar approach Receives: Procedure: Standard total knee arthroplasty |
| Intervention | Experimental | Total knee arthroplasty performed through medial parapatellar approach with identification, ligation, and burial of saphenous nerve branches Receives: Procedure: Total knee arthroplasty with Saphenous nerve burial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of neuralgia
Measured by DN4 validated scoring tool
Measured: 2 years
Secondary outcomes (2)
Oxford Knee Score
Measured: 2 years
Kneeling weight
Ability to kneel with body weight on affected knee
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startAug 2013
- Primary completionMay 2018
- Study completionMay 2018
Why it stopped: Terminated by IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuralgiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885467
- Sponsor's protocol ID
- IRB 2013-281
- Status last verified
- May 2018
- First submitted
- 26 Aug 2016
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saphenous Nerve Brach Burial for Preventing Neuralgia After Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02885467
- Acronym / sponsor ID
- IRB 2013-281
- Conditions
- Neuralgia, Osteoarthritis of the Knee
- Keywords
- Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated by IRB
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 31 Aug 2016 (estimated)
- 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 is a randomized study investigating whether identification, ligation, and burial of superficial branches of the saphenous nerve crossing the surgical field during total knee arthroplasty reduces the rate of post-operative anterior knee pain and neuralgia compared to standard total knee arthroplasty.
Detailed description
Anterior knee pain is common after total knee arthroplasty. The incision necessarily travels through the path of a cutaneous nerve - branches of the saphenous nerve. Historically, no effort has been made to separate these branches and bury them away from the surgical scar. It has been noted that some patients develop a painful neuroma, that once resected results in a pain free knee. Investigators are trying to study if identification, ligation, and proper burial of the nerve can prevent the development of neuralgia compared to the typical surgical approach which ignores the nerve branches completely.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Standard total knee arthroplastyStandard total knee arthroplasty performed through medial parapatellar approach |
| Intervention | Experimental | Procedure: Total knee arthroplasty with Saphenous nerve burialTotal knee arthroplasty performed through medial parapatellar approach with identification, ligation, and burial of saphenous nerve branches |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must have symptomatic knee osteoarthritis under consideration for total knee arthroplasty
- Must be willing to undergo randomization
Key exclusion criteria (10 listed)
- Age <18 or >80 years
- Known pre-operative diagnosis of neuralgia, complex regional pain syndrome, or neuropathy, about the operative lower extremity
- Known pre-operative psychiatric disorder requiring medication
- Previous surgery about the operative knee
- BMI > 40 kg/m2 (potential increased risk of soft tissue dissection through adipose)
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 |
|---|---|---|
| Total knee arthroplasty with Saphenous nerve burial | Procedure or surgery | Intervention |
| Standard total knee arthroplasty | Procedure or surgery | Control |
Primary outcome
Incidence of neuralgia
Time frame: 2 years
Measured by DN4 validated scoring tool
2 secondary outcomes
Oxford Knee Score
Time frame: 2 years
Kneeling weight
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Terminated by IRB). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
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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 Total knee arthroplasty with Saphenous nerve burial and Standard total knee arthroplasty in people with Neuralgia and Osteoarthritis of the Knee, run by Medstar Health Research Institute 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 2 inclusion and 10 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: stopped early, as of the sponsor's last update on 21 May 2018. 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?
The study was stopped early (reason given: Terminated by IRB). Results are not available in the source record.
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?
Incidence of neuralgia (time frame: 2 years). 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 21 May 2018.