Patellar DislocationNCT02267564
MPFL Reconstruction With or Without Tibial Tubercle Transfer
A study testing MPFL reconstruction and tibial tubercle transfer in people with Patellar Dislocation, run by Yu Jiakuo at 1 site in China.
Trial summary
This study aims to compare the clinical outcome of Medial PatelloFemoral Ligament (MPFL) reconstruction with and without tibial tubercle transfer for recurrent patellar dislocation. Read more about this study
- Who is it for?
- Ages Up to 40 years
- Conditions the study is for
- Patellar Dislocation
- What is being tested?
- MPFL reconstruction and tibial tubercle transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Aug 2025
- Phase
- Interventional
- 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 Up to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- recurrent patellar dislocation or instability,patients with TT-TG value equal to or greater than 20 mm,patients with closed epiphyseal plate
- TT-TG：Two lines drawn perpendicular to posterior bicondylar line, one line through middle of the trochlear groove(TG) and the second through tibial tuberosity (TT). Distance between the lines is measured.
Who cannot join
- bilateral patellar dislocation, a previous surgery in the involved leg,patients with open epiphyseal plate,patients with severe trochlear dysplasia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Jia-Kuo Yu, Doctor, 861082267392
Jia-Kuo Yu, Doctor
About this study
Official title: Medial Patellofemoral Ligament (MPFL) Reconstruction With or Without Tibial Tubercle Transfer for Recurrent Patellar Instability
This study aims to compare the clinical outcome of Medial PatelloFemoral Ligament (MPFL) reconstruction with and without tibial tubercle transfer for recurrent patellar dislocation.
Read the detailed description
70 patients with recurrent patellar instability were randomly assigned to undergo MPFL reconstruction with or without tibial tubercle transfer. Follow-ups were performed at 12 and 24 months postoperatively, and computed tomography (CT) was performed immediately after the operation and at follow-up. The knee function was evaluated preoperatively and at 2 years postoperatively using Lysholm,Tegner and Kujala scales. Redislocation or multiple episodes of patellar instability were considered failures.
- Conditions
- Patellar Dislocation
- Being tested
- MPFL reconstruction, tibial tubercle transfer
- Keywords
- patellar dislocation, medial patellofemoral ligament, tibial tubercle transfer
- Medical subject headings
- Patellar Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPFL reconstructionProcedure or surgery
to correct patellar dislocation with medial patellofemoral ligament reconstruction
tibial tubercle transferProcedure or surgery
to correct patellar dislocation with tibial tubercle medial transfer
| Study group | Role | What they receive |
|---|---|---|
| MPFLR without tibial tubercle transfer | Experimental | Patients with patellar instability undergo MPFL reconstruction without tibial tubercle transfer. Receives: Procedure: MPFL reconstruction; Procedure: tibial tubercle transfer |
| MPFLR with tibial tubercle transfer | Active comparator | Patients with patellar instability undergo MPFL reconstruction with tibial tubercle transfer. Receives: Procedure: MPFL reconstruction; Procedure: tibial tubercle transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm score of the knee
Lysholm score of the knee was evaluated preoperatively and at 2 years post operation .
Scale name:score
Measured: two years
Tegner score of the knee
Tegner score of the knee was evaluated preoperatively and at 2 years post operation .
Scale name:score
Measured: two years
Kujala score of the knee
Kujala score of the knee was evaluated preoperatively and at 2 years post operation .
Measured: two years
Secondary outcomes (1)
CT images of the knee
CT was performed immediately after the operation and at follow-up.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar DislocationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yu Jiakuo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu Jiakuo, Peking University Third Hospital
- Investigators
- Jia-Kuo Yu, Doctor, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267564
- Sponsor's protocol ID
- 2014099
- Status last verified
- Jun 2023
- First submitted
- 28 Sep 2014
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medial Patellofemoral Ligament (MPFL) Reconstruction With or Without Tibial Tubercle Transfer for Recurrent Patellar Instability
- ClinicalTrials.gov ID
- NCT02267564
- Acronym / sponsor ID
- 2014099
- Conditions
- Patellar Dislocation
- Keywords
- patellar dislocation, medial patellofemoral ligament, tibial tubercle transfer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Yu JiakuoUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 17 Oct 2014 (estimated)
- 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.
This study aims to compare the clinical outcome of Medial PatelloFemoral Ligament (MPFL) reconstruction with and without tibial tubercle transfer for recurrent patellar dislocation.
Detailed description
70 patients with recurrent patellar instability were randomly assigned to undergo MPFL reconstruction with or without tibial tubercle transfer. Follow-ups were performed at 12 and 24 months postoperatively, and computed tomography (CT) was performed immediately after the operation and at follow-up. The knee function was evaluated preoperatively and at 2 years postoperatively using Lysholm,Tegner and Kujala scales. Redislocation or multiple episodes of patellar instability were considered failures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPFLR without tibial tubercle transfer | Experimental | Procedure: MPFL reconstruction, Procedure: tibial tubercle transferPatients with patellar instability undergo MPFL reconstruction without tibial tubercle transfer. |
| MPFLR with tibial tubercle transfer | Active comparator | Procedure: MPFL reconstruction, Procedure: tibial tubercle transferPatients with patellar instability undergo MPFL reconstruction with tibial tubercle transfer. |
Who may qualify
- Ages
- Up to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- recurrent patellar dislocation or instability,patients with TT-TG value equal to or greater than 20 mm,patients with closed epiphyseal plate
- TT-TG：Two lines drawn perpendicular to posterior bicondylar line, one line through middle of the trochlear groove(TG) and the second through tibial tuberosity (TT). Distance between the lines is measured.
Key exclusion criteria (1 listed)
- bilateral patellar dislocation, a previous surgery in the involved leg,patients with open epiphyseal plate,patients with severe trochlear dysplasia
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 |
|---|---|---|
| MPFL reconstructionto correct patellar dislocation with medial patellofemoral ligament reconstruction | Procedure or surgery | MPFLR with tibial tubercle transfer, MPFLR without tibial tubercle transfer |
| tibial tubercle transferto correct patellar dislocation with tibial tubercle medial transfer | Procedure or surgery | MPFLR with tibial tubercle transfer, MPFLR without tibial tubercle transfer |
Primary outcome
Lysholm score of the knee
Time frame: two years
Lysholm score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score
Tegner score of the knee
Time frame: two years
Tegner score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score
Kujala score of the knee
Time frame: two years
Kujala score of the knee was evaluated preoperatively and at 2 years post operation .
1 secondary outcome
CT images of the knee
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
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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.
Jia-Kuo Yu, Doctor study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPFL reconstruction and tibial tubercle transfer in people with Patellar Dislocation, run by Yu Jiakuo at 1 site in China.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Jun 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia-Kuo Yu, Doctor (861082267392, yujiakuo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm score of the knee (time frame: two years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2023.