Effect of J-Shaped Incision After Total Knee Arthroplasty (J-TKA) (NCT07514598) | Clinical Trial Compass
CompletedNot Applicable
Effect of J-Shaped Incision After Total Knee Arthroplasty (J-TKA)
Turkey (Türkiye)62 participantsStarted 2025-09-17
Plain-language summary
This prospective randomized controlled trial evaluates whether a modified J-shaped skin incision can reduce peri-incisional numbness after primary total knee arthroplasty (TKA) compared with the conventional midline skin incision. Peri-incisional numbness is a common postoperative complaint after TKA and is thought to be mainly related to injury of the infrapatellar branch of the saphenous nerve. Although often considered a minor issue, it may adversely affect postoperative comfort, pain perception, and patient satisfaction.
A total of 62 patients undergoing primary TKA for Kellgren-Lawrence grade 4 varus knee osteoarthritis were randomized to either a conventional midline incision or a modified J-shaped incision. In the J-shaped technique, the distal part of the incision is curved laterally at the level of the tibial tuberosity in an effort to decrease injury to the infrapatellar branch of the saphenous nerve. The primary outcome is the extent of peri-incisional sensory loss, assessed using Semmes-Weinstein 10-g monofilament testing with a grid-mapping method before surgery and at 2 and 6 months after surgery. Secondary outcomes include pain scores, functional knee scores, range of motion, blood loss, tourniquet time, and wound-related complications.
Who can participate
Age range
56 Years – 81 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults undergoing primary total knee arthroplasty
* Diagnosis of Kellgren-Lawrence grade 4 varus knee osteoarthritis
* Planned treatment with primary total knee arthroplasty
* Ability to provide written informed consent
* Ability to comply with postoperative follow-up evaluations
Exclusion Criteria:
* Valgus knee deformity
* Revision total knee arthroplasty
* Previous surgery on the affected knee
* History of periarticular fracture around the knee
* Pre-existing sensory deficit or neurologic disorder affecting the operative lower extremity
* History of lumbar disc herniation
* Known neuromuscular disease
* Peripheral vascular disease
* Inability to comply with follow-up and postoperative evaluations
* Refusal or inability to provide informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area of peri-incisional sensory loss
Timeframe: 2 months and 6 months postoperatively
Trial details
NCT IDNCT07514598
SponsorFatih Sultan Mehmet Training and Research Hospital