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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06251765
Other study ID # JUD-TR
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2024
Est. completion date November 2024

Study information

Verified date May 2024
Source Istituto Ortopedico Rizzoli
Contact Giulio Maria Marcheggiani Muccioli, MD PhD
Phone 051 636
Email giuliomaria.marcheggianimuccioli@ior.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Post-traumatic Extension Contracture of the Knee (PECK) is a common complication following knee traumas. It is characterized by a restricted Range of Motion (ROM), pain, and discomfort in the affected knee. Various factors can cause PECK, primarily inflammation and scar tissue formation. The underlying inflammatory state leads to the development of scar tissue, which - when combined with immobilization - results in the progressive stiffness of the knee. Additionally, prolonged immobilization leads to muscle atrophy and, consequently, reduced mobility and increased rigidity. All these conditions contribute to a limited ROM, making it challenging to perform various daily activities. Sometimes conservative treatments can be effective, but surgery is often necessary to restore joint functionality and alleviate pain. Historically, various surgical approaches have been proposed to address post-traumatic knee stiffness. Open surgery is typically reserved for cases where arthroscopic adhesion release and manipulation under anesthesia have not been successful. Over the last century, various open surgical techniques have been proposed. In particular, arthromyolysis according to Judet was first described in the 1950s by the French orthopedic surgeon Jacques Judet. This technique involves a series of incisions and soft tissue releases, allowing the surgeon to resolve the stiffness of the quadriceps tendon caused by trauma or prolonged immobilization. Although effective in restoring knee joint functionality, arthromyolysis according to Judet is not without risks and potential complications. These include infection, massive bleeding, nerve and muscle-tendon injuries, and residual stiffness. The purpose of this study is to analyze our case series related to arthromyolysis according to Judet for PECK. Clinical outcomes, complications, and patient satisfaction following this type of intervention will be evaluated.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date November 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adult patients underwent surgical intervention for arthromyolysis according to Judet with modified surgical technique for knee stiffness from January 2008 to December 2019. 2. Patients with post-traumatic injuries (fractures treated surgically). 3. Patients with a minimum of 4 years of follow-up. 4. Completeness of clinical documentation. Exclusion Criteria: 1. Patients who underwent surgical intervention for arthrolysis (both arthroscopic and non-arthroscopic) or arthromyolysis according to Judet with minimally invasive technique. 2. Patients who underwent surgery to address knee stiffness due to other causes (rigid prosthesis, limb lengthening, etc.). 3. Incomplete clinical documentation.

Study Design


Related Conditions & MeSH terms

  • Stiffness of Knee, Not Elsewhere Classified

Intervention

Other:
Clinical scores
Clinical scores will be administered to patients
Range of Motion
Evalutation of knee mobility

Locations

Country Name City State
Italy IRCCS Istituto Ortopedico Rizzoli Bologna

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Bidolegui F, Pereira SP, Pires RE. Safety and efficacy of the modified Judet quadricepsplasty in patients with post-traumatic knee stiffness. Eur J Orthop Surg Traumatol. 2021 Apr;31(3):549-555. doi: 10.1007/s00590-020-02802-3. Epub 2020 Oct 13. — View Citation

Luo Y, Li H, Mei L, Mao X. Effects of Judet Quadricepsplasty in the Treatment of Post-traumatic Extension Contracture of the Knee. Orthop Surg. 2021 Jun;13(4):1284-1289. doi: 10.1111/os.12950. Epub 2021 May 6. — View Citation

Pujol N, Boisrenoult P, Beaufils P. Post-traumatic knee stiffness: surgical techniques. Orthop Traumatol Surg Res. 2015 Feb;101(1 Suppl):S179-86. doi: 10.1016/j.otsr.2014.06.026. Epub 2015 Jan 9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Range of Motion at follow-up ROM expresses in degrees the degree of range of motion that a joint can perform along its full range of motion whether active or passive through an external aid. baseline time 0
Secondary Intra-operative Range of Motion ROM expresses in degrees the degree of range of motion that a joint can perform along its full range of motion whether active or passive through an external aid. baseline time 0
Secondary Knee injury and Osteoarthritis Outcome Score KOOS assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment. baseline time 0
Secondary Tegner Activity Scale Tegner Activity Scale is used in order to provide a standardized method to grade work and sporting activities. baseline time 0
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