UMIN-CTR Clinical Trial

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

Knee anterior cruciate ligament rupture

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

University of Miyazaki Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

University of Miyazaki Research Support Center

Address

University of Miyazaki Hospital

Tel

0985850986

Email

seikei@med.miyazaki-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

03

Month

15

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2019

Year

03

Month

15

Day

Last modified on

2019

Year

03

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041247