Knee FracturesNCT06251765
Clinical Results After Judet Quadricepsplasty for Post-traumatic Knee Stiffness
An observational study of Knee Fractures and Stiffness of Knee, Not Elsewhere Classified, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Fractures, Stiffness of Knee, Not Elsewhere Classified
- What is being tested?
- Clinical scores and Range of Motion
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jul 2024to 18 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent Judet arthromyolisis for treatment of post-traumatic knee-stiffness
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Results After Judet Quadricepsplasty for Post-traumatic Knee Stiffness: a Retrospective and Prospective Observational Study
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.
Read more
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.
- Being tested
- Clinical scores, Range of Motion
- Keywords
- arthromyolisis, Judet, post-traumatic, quadricepsplasty
- Medical subject headings
- Knee Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical scoresOther
Clinical scores will be administered to patients
Range of MotionOther
Evalutation of knee mobility
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients who underwent Judet arthromyilisis for treatment of post-traumatic knee stiffness Receives: Other: Clinical scores; Other: Range of Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline time 0
Secondary outcomes (3)
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.
Measured: baseline time 0
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.
Measured: baseline time 0
Tegner Activity Scale
Tegner Activity Scale is used in order to provide a standardized method to grade work and sporting activities.
Measured: baseline time 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start10 Jul 2024
- Primary completion18 Oct 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee FracturesStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251765
- Sponsor's protocol ID
- JUD-TR
- Status last verified
- Oct 2024
- First submitted
- 1 Feb 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25583236Luo 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.
PubMed 33955701Bidolegui 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.
PubMed 33051692
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Results After Judet Quadricepsplasty for Post-traumatic Knee Stiffness: a Retrospective and Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06251765
- Acronym / sponsor ID
- JUD-TR
- Keywords
- arthromyolisis, Judet, post-traumatic, quadricepsplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Clinical scores, Other: Range of MotionPatients who underwent Judet arthromyilisis for treatment of post-traumatic knee stiffness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent Judet arthromyolisis for treatment of post-traumatic knee-stiffness
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical scoresClinical scores will be administered to patients | Other | Patients |
| Range of MotionEvalutation of knee mobility | Other | Patients |
Primary outcome
Range of Motion at follow-up
Time frame: baseline time 0
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.
3 secondary outcomes
Intra-operative Range of Motion
Time frame: baseline time 0
Knee injury and Osteoarthritis Outcome Score
Time frame: baseline time 0
Tegner Activity Scale
Time frame: baseline time 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Results publication: PubMed 25583236Pujol 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.
- Results publication: PubMed 33955701Luo 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.
- Results publication: PubMed 33051692Bidolegui 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.
- Individual participant dataSharing planned: No
Related trials for Knee Fractures
Active, not recruiting
Comparison of Functional Results and Complications Between K-Wire Tension Band Fixation and Interosseous Suturing in Transverse Patellar Fractures: A Randomized Controlled Trial
Patella Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
Not yet recruiting
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
Tibial Plateau Fracture
Active, not recruitingObservational study
Evaluation of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty
Osteoarthritis, Knee, Arthritis, Rheumatoid
RecruitingObservational study
Comparison of Knee Muscle Function After Suprapatellar and Infrapatellar Tibial Nailing in Patients With Tibial Shaft Fractures
Tibia Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Fractures and Stiffness of Knee, Not Elsewhere Classified, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion at follow-up (time frame: baseline time 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06251765, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.