Clinical Results After Judet Quadricepsplasty for Post-tr... | NCT06251765

Studies
Clinical Results After Judet Quadricepsplasty for Post-traumatic Knee Stiffness

NCT06251765

Sponsor

Istituto Ortopedico Rizzoli

Status

Completed

Last Update Posted

Oct 21, 2024Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Knee Fractures
Stiffness of Knee, Not Elsewhere Classified

Interventions

Clinical scores
Range of Motion

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2024Actual

Primary Completion Date

Oct 18, 2024Actual

Completion Date

Oct 18, 2024Actual

First Submitted Date

Feb 1, 2024

First Submission Date that Met QC Criteria

Feb 1, 2024

First Posted Date

Feb 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2024

Last Update Posted Date

Oct 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients		Patients who underwent Judet arthromyilisis for treatment of post-traumatic knee stiffness	Other: Clinical scores Other: Range of Motion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clinical scores	Other	Clinical scores will be administered to patients	Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
Knee injury and Osteoarthritis Outcome Score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients underwent surgical intervention for arthromyolysis according to Judet with modified surgical technique for knee stiffness from January 2008 to December 2019.
Patients with post-traumatic injuries (fractures treated surgically).
Patients with a minimum of 4 years of follow-up.
Completeness of clinical documentation.

Exclusion Criteria:

Patients who underwent surgical intervention for arthrolysis (both arthroscopic and non-arthroscopic) or arthromyolysis according to Judet with minimally invasive technique.
Patients who underwent surgery to address knee stiffness due to other causes (rigid prosthesis, limb lengthening, etc.).
Incomplete clinical documentation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent Judet arthromyolisis for treatment of post-traumatic knee-stiffness

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Istituto Ortopedico Rizzoli		Bologna		40136	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25583236	Result	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.
33955701	Result	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.

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D007718	Knee Injuries
D007869	Leg Injuries

ID	Term
D010808	Physical Examination
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D009142	Musculoskeletal Physiological Phenomena