Surgical Treatment for Ankle Equinus

(Plantaris Sx Trial)

Overseen By Collaborative Orthopaedic Research (CORe)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Must not be taking: Botulinum toxin

Disqualifiers: Previous surgery, Limb deficiency, others

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

Compensation: Varies

Number of Visits: 2

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether targeting a specific small muscle in the leg, the plantaris, can improve treatment for children with ankle equinus. Ankle equinus makes it difficult to pull the foot upward, leading to walking problems and long-term foot issues. Participants will undergo surgery to lengthen the plantaris muscle alongside other standard procedures, and researchers will compare the results. The trial seeks children who struggle with conditions like cerebral palsy or toe walking and plan to have surgery to manage ankle tightness. Understanding the plantaris muscle's role could lead to better treatments for children with tight ankles. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatments for children with similar conditions.

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 surgical treatment is safe for children with ankle equinus?

Research has shown that focusing on the plantaris muscle-tendon during surgeries for ankle equinus is generally safe. Previous studies on similar treatments have demonstrated positive results. For instance, one study found that removing the plantaris tendon during surgery led to good outcomes, with patients experiencing fewer complications and requiring fewer follow-up surgeries.

Another method studied is percutaneous needle tenotomy, a minimally invasive procedure that cuts tight tendons. This method has proven safe, even for patients with other health issues. This suggests that procedures targeting tendons, like the plantaris, are well-tolerated.

Overall, existing evidence supports the safety of focusing on the plantaris muscle-tendon in treating ankle equinus. This is promising for those considering participation in clinical trials for this condition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these surgical treatments for ankle equinus because they explore new approaches to addressing muscle tightness and limited range of motion. Unlike traditional methods that often involve physical therapy, casting, or standalone surgical techniques, these treatments combine Plantaris tenotomy with either Tendoachilles (TA) lengthening or gastrocnemius (GN) recession. This dual approach aims to improve flexibility and mobility more effectively by targeting multiple components of the calf muscle complex. Additionally, by varying the order of these procedures, researchers hope to discover the most effective sequence for maximizing patient outcomes.

What evidence suggests that targeting the plantaris muscle could be effective for treating ankle equinus?

Research has shown that focusing on the plantaris muscle can greatly improve ankle movement in people with ankle equinus. In this trial, participants will undergo different surgical sequences involving the plantaris muscle. One group will receive Plantaris tenotomy surgery before Tendoachilles (TA) lengthening or gastrocnemius (GN) recession, while another group will undergo Tendoachilles (TA) lengthening or gastrocnemius (GN) recession before Plantaris tenotomy. Previous studies have demonstrated that simply cutting the plantaris tendon improved ankle movement by over 50%. Another study identified the plantaris muscle as a key factor in causing this condition. This suggests that treating the plantaris muscle might effectively help children with ankle equinus. Treatments targeting this muscle could lead to better walking and less pain. ^{2 6 7 8 9}

Who Is on the Research Team?

Sukhdeep Dulai, MD, MHSc, FRCSC

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for children with conditions like Cerebral Palsy or Spinal Cord Injury that cause tight ankle muscles, limiting their ability to pull the foot upward. They must be undergoing surgery for ankle equinus and can't have other treatments planned.

Inclusion Criteria

I am a child (4-17) scheduled for surgery to correct foot tightness at Stollery Children's Hospital.

I can keep my heel and midfoot stable during an exam.

I have a condition like cerebral palsy or had a stroke that affects how I walk.

Exclusion Criteria

I have a limb deficiency on one side.

I have had surgery on my leg below the knee in the past year.

I have not had Botox injections below my knee in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgical Intervention

Participants undergo surgical intervention for ankle equinus, including plantaris tenotomy and either Tendoachilles lengthening or gastrocnemius recession

Single surgical session

1 visit (in-person)

Intra-operative Assessment

Maximum passive ankle dorsiflexion is measured at several intervals during surgery

During surgery

Follow-up

Participants are monitored for safety and effectiveness after surgical intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Plantaris Muscle-tendon Targeting

Trial Overview The study tests if changing the order of lengthening the plantaris muscle affects treatment outcomes in ankle equinus. Children are randomly assigned to have plantaris lengthened before or after gastrocsoleus lengthening, all in one surgery session.

How Is the Trial Designed?

Group I: Tendoachilles (TA) lengthening or gastrocnemius (GN) recession, then Plantaris tenotomy Experimental Treatment 1 Intervention

Participants undergo Tendoachilles (TA) lengthening or gastrocnemius (GN) recession surgery before Plantaris tenotomy.

Group II: Plantaris tenotomy, then Tendoachilles (TA) lengthening or gastrocnemius (GN) recession Experimental Treatment 1 Intervention

Participants undergo Plantaris tenotomy surgery before Tendoachilles (TA) lengthening or gastrocnemius (GN) recession.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Citations

1. scitrialsfinder.net scitrialsfinder.net/trials/NCT07090057

The Effect of Targeting the Plantaris Muscle-tendon in The Effect of Targeting the Plantaris Muscle-tendon in Surgical Correction of Ankle Equinus in Children ... plantaris tenotomy significantly improves passive ...

2. patlynk.com patlynk.com/trial/NCT07090057

Targeting Plantaris Muscle-tendon Unit in Ankle Equinus ... This study focuses on children who have a walking condition known as equinus gait, where the ability to flex the ankle upwards is reduced, often leading to ...

3. acfas.org acfas.org/getattachment/62aacb41-3853-408a-b151-ac27b75a4f1a/POST2018_SCI-1020.pdf?lang=en-US

Is the Plantaris Muscle a Significant Deforming Force in the ... The plantaris tendon was not identifiable in 6 (15%) of these patients. The results of this study show that the plantaris plays a significant role in equinus ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1067251622002150

The Role of the Plantaris in Intramuscular Gastrocnemius ... Our results indicate that the plantaris plays an important role in equinus deformity. Transection of the plantaris tendon alone provided greater than 50% of the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10149292/

The efficacy of split tibial tendon transfers on functional gait ... Successful outcomes equal total of excellent and good, able to walk with a plantar grade foot < 5° varus, valgus, or equinus, normal shoe wear, ...

6. app.trialscreen.org app.trialscreen.org/trials/effect-targeting-plantaris-muscle-tendon-surgical-correction-ankle-equinus-trial-nct07090057

The Effect of Targeting the Plantaris Muscle-tendon in ... Data will be collected from 42 children undergoing surgical intervention for ankle equinus. Subjects will be randomly allocated into two ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12202896/

Achilles Tendon Scraping With Plantaris Tendon Removal ... ATS with PTR demonstrated promising preliminary results, with improved postoperative PROs, high reported rates of RTA/RTS, and low complication and revision ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S187706572400023X

Percutaneous needle tenotomies: indications, procedures ... Percutaneous needle tenotomies constitute a promising approach that enables direct access to tendons through minimally invasive interventions.

9. archives-pmr.org archives-pmr.org/article/S0003-9993(16)31308-9/fulltext

Percutaneous Needle Tenotomy for the Treatment ... Percutaneous needle tenotomy of superficial tendon contractures is safe in frail patients with neurologic diseases.