Study on Percutaneous Needle Fasciotomy with Methylprednisolone Acetate or Saline for Dupuytren’s Contracture in the Finger Joint

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What is this study about?

This clinical trial is focused on studying a condition called Dupuytren’s Contracture, which affects the hand, specifically the joints that connect the fingers to the palm. In this condition, the fingers bend towards the palm and cannot be fully straightened. The study is exploring a treatment method called Percutaneous Needle Fasciotomy (PNF), which involves using a needle to cut the thickened tissue in the palm. The trial will compare the effectiveness of PNF when combined with a corticosteroid injection using a medication called Depo-Medrol (methylprednisolone acetate) against PNF with a simple saline injection, which acts as a placebo.

The purpose of the study is to determine if adding a corticosteroid injection to the PNF procedure provides better long-term results in reducing the recurrence of the contracture. The corticosteroid is a type of medication that helps reduce inflammation and is mixed with a local anesthetic called lidocaine to minimize discomfort during the injection. Participants in the study will receive either the corticosteroid and lidocaine mixture or the saline injection after undergoing the PNF procedure.

Throughout the study, participants will be monitored to assess the improvement in their hand function and the degree to which their fingers can be straightened. The study aims to find out if the combination of PNF and corticosteroid injection leads to a lower chance of the contracture returning compared to PNF alone. The trial will also track any side effects or complications that may arise from the treatments. Participants will be followed over time to evaluate the effectiveness and safety of the treatment options being tested.

1 enrollment and consent

Upon joining the study, you will be asked to provide written consent, confirming your willingness to participate. This involves understanding the trial’s purpose and procedures.

You will receive both oral and written information about the trial to ensure you are fully informed before signing the consent form.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes measuring the passive extension deficit (PED) in your affected finger joint using a finger goniometer.

The assessment will also involve identifying a well-defined or palpable cord in the affected finger.

3 randomization

You will be randomly assigned to one of two groups: one receiving corticosteroid injection and the other receiving a saline injection as a placebo.

This process ensures that the study results are unbiased and scientifically valid.

4 treatment administration

If assigned to the corticosteroid group, you will receive an injection of Depo-Medrol 40 mg/1 ml (methylprednisolone acetate) and XYLOCAINE 10 mg/ml (anhydrous lidocaine hydrochloride) as a solution for injection.

If assigned to the placebo group, you will receive an injection of 2 ml of isotonic saline (9 mg/ml).

The injection is administered as a solution for injection directly into the affected area.

5 follow-up assessments

Regular follow-up assessments will be scheduled to monitor your progress and evaluate the treatment’s effectiveness.

These assessments will measure changes in the passive extension deficit and other related outcomes, such as the ability to straighten the joint and any complications or adverse events.

6 final evaluation

At the end of the trial, a final evaluation will be conducted to assess the long-term results of the treatment.

The primary focus will be on the recurrence of the condition, defined as a passive extension deficit of 20 degrees or more in the affected joint.

Who Can Join the Study?

Must be at least 45 years old.
Have a condition called Dupuytren Contracture with a finger that cannot fully straighten, showing a bending of at least 20 degrees at the knuckle closest to the palm. This is measured with a tool called a finger goniometer.
The affected finger must be one of the following: index, middle, ring, or little finger.
Have a well-defined or easily felt cord in the palm or finger.
Must have received both oral and written information about the trial before joining.
Must be willing to participate and have signed a written consent form agreeing to join the study.

Who Cannot Join the Study?

Patients who have had surgery for Dupuytren Contracture in the past 6 months cannot participate. Dupuytren Contracture is a condition where the fingers bend towards the palm and cannot be fully straightened.
Patients with other hand conditions that affect movement or function are not eligible.
Patients who have received a corticosteroid injection in the affected hand in the last 3 months are excluded. A corticosteroid injection is a shot that reduces inflammation and pain.
Patients with a known allergy to corticosteroids or any component of the injection cannot join. An allergy is when your body reacts badly to something.
Patients with an active infection in the hand or arm are not allowed to participate.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients with a history of poor wound healing or significant scarring are excluded.
Patients who are unable to attend follow-up visits as required by the study are not eligible.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Regionshospitalet Silkeborg	Silkeborg	Denmark
Regionshospitalet Horsens	Horsens	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.10.2022

Trial locations

Investigated drugs:

Corticosteroid Injection is a treatment used in this trial to help reduce inflammation and pain. It involves injecting a medication directly into the affected area, in this case, the hand joint affected by Dupuytren Contracture. The goal of using corticosteroids is to improve the long-term results of the procedure by potentially reducing the chance of the condition coming back.

Percutaneous Needle Fasciotomy (PNF) is a minimally invasive procedure used to treat Dupuytren Contracture. In this procedure, a needle is used to cut the thickened tissue in the palm that is causing the fingers to bend towards the palm. This helps to straighten the fingers and improve hand function. The trial is investigating whether combining this procedure with a corticosteroid injection provides better outcomes than the procedure alone.

Investigated diseases:

Dupuytren's contracture

Dupuytren Contracture – Dupuytren Contracture is a hand condition where the fingers bend towards the palm due to thickening and shortening of the tissue under the skin. It typically starts as small nodules in the palm, which can develop into thick cords. Over time, these cords can pull one or more fingers into a bent position, making it difficult to straighten them. The condition progresses slowly and can affect the ability to perform everyday tasks. It most commonly affects the ring and little fingers. The progression varies among individuals, with some experiencing rapid changes and others having a more gradual development.

Trial ID:

2022-501549-57-00

Protocol code:

2022-985

NCT ID:

NCT05440240

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Percutaneous Needle Fasciotomy with Methylprednisolone Acetate or Saline for Dupuytren’s Contracture in the Finger Joint

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?