UMIN-CTR Clinical Trial

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
Email	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
Email	tachibanayuta@gmail.com

Sponsor
Institute	Osaka Rosai Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051205