UMIN-CTR Clinical Trial

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
Last 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
1st 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