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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036212
Receipt No. R000041247
Scientific Title Prospective comparisons of femoral tunnel enlargement with two different postoperative non weight bearing periods after double-bundle anterior cruciate ligament reconstruction with hamstring grafts
Date of disclosure of the study information 2019/03/15
Last modified on 2019/03/15

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Basic information
Public title Prospective comparisons of femoral tunnel enlargement with two different postoperative non weight bearing periods after double-bundle anterior cruciate ligament reconstruction with hamstring grafts
Acronym Prospective comparisons of femoral tunnel enlargement with two different postoperative non weight bearing periods after double-bundle anterior cruciate ligament reconstruction with hamstring grafts
Scientific Title Prospective comparisons of femoral tunnel enlargement with two different postoperative non weight bearing periods after double-bundle anterior cruciate ligament reconstruction with hamstring grafts
Scientific Title:Acronym Prospective comparisons of femoral tunnel enlargement with two different postoperative non weight bearing periods after double-bundle anterior cruciate ligament reconstruction with hamstring grafts
Region
Japan

Condition
Condition Knee anterior cruciate ligament rupture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Bone tunnel enlargement following primary anterior cruciate ligament (ACL) reconstruction with soft tissue graft might be a severe disadvantage for revision surgery. The postoperative rehabilitation protocol including the non-weight-bearing periods were different depending on the surgeon or institute. To determine the relationship between femoral bone tunnel enlargement and the postoperative non-weight-bearing period after double-bundle ACL reconstruction with hamstring grafts.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bone tunnel enlargement was evaluated by computed digital radiographs (anteroposterior (A-P) and lateral views) taken on the first postoperative day and at 12 months.
Key secondary outcomes 1.knee extension and flexion muscle strength
2.side to side difference
3.knee range of motion

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 These cases who were undergoing primary double-bundle ACL reconstruction with hamstring grafts were allocated into two different postoperative non-weight-bearing protocol groups; the allocation was conducted in a serial consecutive, not randomized,fashion:the first consecutive group of patients(Group A)received 1 week of non-weight-bearing postoperatively;the second consecutive group of patients received 2 weeks of non-weight-bearing Group B).In the operation room,the knee was immobilized with a brace with the knee positioned in the angle 20 of flexion for both groups to maintain the same angle as during graft fixation at surgery to avoid stress on the grafts. After the protocol immobilization period, range of motion exercises were performed gradually, with knee flexion of 10 degrees started with a locked hard brace for 1 week, following which full extension was allowed for both groups. In group A, partial weight-bearing was started at 1 week following surgery, with full weight-bearing at 4 weeks. For group B, partial weight-bearing was started at 2 weeks after surgery, with full weight-bearing at 5 weeks. Therefore, the non-weight-bearing period of group A was 1 week, and that of group B was 2 weeks. All patients used the knee brace for the first 3 months after surgery. Jogging and running were allowed at 3 months postoperatively. Return to the athletic movement such as jumping or cutting actions were allowed at 6 months. and return to full sports activity was no sooner than 8 months after surgery
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subject
The present prospective, comparative clinical research was conducted in 2014, involving patients who underwent double-bundle ACL reconstruction with hamstring tendon autografts, under the same surgical technique and the same surgical devices at our institute. The experimental design was reviewed and approved by the Committee for Ethics at our institution. The procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000. We obtained written, informed consent form from all patients and guardians for publication of this report and any accompanying images. As control, data of the patients who underwent ACL reconstruction with same procedure at 2012-13 in our institute were employed.
Selection Criteria
1.Patients who completed the rehabilitation protocol during the follow-up period

2. Patients who could collected the full clinical and radiological data available, such as general clinical scores, knee extension/flexion muscle strength measurements, and femoral bone tunnel enlargement measured by digital radiography of the knee 12 months postoperatively.
Key exclusion criteria 1.knee multiple ligament injury cases
2.ACL reconstruction with meniscal repair cases
3.The genu recurvatum cases
4.Re-injury cases
5.Under 15 years old cases
6.other unsuitable cases
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Chosa
Middle name
Last name Etsuo
Organization University of Miyazaki Hospital
Division name Orthopaedic Surgery
Zip code 8891692
Address 5200 Kihara Kiyotake Miyazaki 889-1692 JAPAN
TEL 0985850986
Email seikei@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name Tajima
Middle name
Last name Takuya
Organization University of Miyazaki Hospital
Division name Orthopaedic Surgery
Zip code 8891692
Address 5200 Kihara Kiyotake Miyazaki 889-1692 JAPAN
TEL 0985850986
Homepage URL
Email seikei@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki Hospital
Institute
Department

Funding Source
Organization None
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 University of Miyazaki Research Support Center
Address University of Miyazaki Hospital
Tel 0985850986
Email seikei@med.miyazaki-u.ac.jp

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
2019 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 28
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 Completed
Date of protocol fixation
2015 Year 03 Month 25 Day
Date of IRB
2015 Year 03 Month 25 Day
Anticipated trial start date
2015 Year 03 Month 25 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 03 Month 15 Day
Last modified on
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041247

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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