UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044829 |
|---|---|
| Receipt number | R000051205 |
| Scientific Title | A study of improvement of the results after posterior cruciate ligament reconstruction |
| Date of disclosure of the study information | 2021/07/12 |
| Last modified on | 2021/07/12 12:35:54 |
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Basic information
Public title
A study of improvement of the results after posterior cruciate ligament reconstruction
Acronym
A study of improvement of the results after posterior cruciate ligament reconstruction
Scientific Title
A study of improvement of the results after posterior cruciate ligament reconstruction
Scientific Title:Acronym
A study of improvement of the results after posterior cruciate ligament reconstruction
Region
| Japan |
Condition
Condition
posterior cruciate ligament injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Posterior cruciate ligament (PCL) is the major stabilizer for posterior tibial translation relative to the femur. PCL injury causes the increase of the contact pressure in the patellofemoral and medial tibiofemoral compartment especially in the knee flexed, and leads to meniscal injuries and osteoarthritis in the long-term observation. Although PCL reconstruction can improve the subjective knee instability, several investigations have shown that the posterior tibial translation still remains after surgery. Our investigations have demonstrated that the tibial posterior translation recurs in the early postoperative term. This postoperative residual posterior tibial translation in the PCL-reconstructed knee can lead the above mentioned degenerative change in the future as well as that in the PCL-deficient knee. Thus, it is important to restore the normal tibiofemoral relationship by PCL reconstruction.
There were few previous studies focusing on the importance of the rehabilitation after PCL reconstruction. Some recent studies warranted that daily activities such as active knee flexion can cause mechanical stress on the transplanted graft and argued that the protective rehabilitation protocols and usage of the functional PCL brace was recommended.
Therefore, this study aimed to prospectively evaluate the effect of these modification of the postoperative management on the results after PCL reconstruction, by comparing the ones with the conventional postoperative management in the past. We hypothesized that the improvement of the postoperative management could prevent the recurrence of the posterior tibial translation after PCL reconstruction and contribute the improved postoperative outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Posterior tibial translation 3 months, 6 months, 1 year, and more than 2 years after surgery
Key secondary outcomes
physical examination
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients underwent reconstruction surgery for isolated posterior cruciate ligament injury in our department were enrolled in this study. The control group consists of 13 patients from January 2017 to December 2018, whereas the intervention group from January 2019. In the intervention group, knee range of motion exercise is started 3 weeks after surgery as in the control group. However, but in the rehabilitation protocol for the intervention group, the patients are laid in the prone position during the passive range of motion exercise until 3 months after surgery, in order to suppress the active contraction of the hamstrings. Additionally, they are instructed to wear a PCL Jack brace, which dynamically creates an anterior load to the tibia, protecting the reconstructed ligament up to 6 months after surgery. On the other hand, in the control group, the range of motion training was performed in the conventional supine position where the posterior load due to the gravity weight of the lower leg could be generated and such a protective orthosis was not used.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who accept our study protocol with isolated posterior cruciate ligament injury
Key exclusion criteria
Patients who suffer from multiple ligament injury or do not accept our study protocol
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Tachibana |
Organization
Osaka Rosai Hospital
Division name
Department of Orthopaedic Surgery
Zip code
591-8025
Address
1179-3, Nagasone-cho,Kita-ku, Sakai, Osaka
TEL
0722523561
tachibanayuta@gmail.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Tachibana |
Organization
Osaka Rosai Hospital
Division name
Department of Orthopaedic Surgery
Zip code
591-8025
Address
1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka
TEL
0722523561
Homepage URL
tachibanayuta@gmail.com
Sponsor or person
Institute
Osaka Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka Rosai Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Rosai Hospital
Address
1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka
Tel
0722523561
tachibanayuta@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 12 | Day |
Last modified on
| 2021 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051205
