Rupture of Anterior Cruciate LigamentNCT04431063

Comparison of the Functional Outcome of Site Peroneus Longus Graft Donors With and Without Distal Stump Suturing of Peroneus Tendon Brevis on ACL Reconstruction Case in Cipto Mangunkusumo Hospital in Jakarta With 24 Patient as Subject Who Will Divide Into 2 Group.

A study testing Distal Stump Suturing in people with Rupture of Anterior Cruciate Ligament, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Any age
Conditions the study is for: Rupture of Anterior Cruciate Ligament
What is being tested?: Distal Stump Suturing
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteIndonesia
Study dates: 1 Dec 2018to 30 Jun 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients with total ACL rupture using peroneus longus graft
The suturing procedure for the distal stump peroneus longus against the peroneus brevis tendon is performed by orthopedic specialists or resident chiefs who have been given training in advance.

Who cannot join

Osteoarthtis Knee Kellgren-Lawrence III and IV
Osteoarthtis Knee Kellgren-Lawrence III and IV
Flatfoot as evidenced by physical examination and footprinting

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

Cipto Mangunkusumo Hospital
Jakarta, DKI Jakarta, 14250

Other trials in Indonesia

About this study

Official title: Comparison of the Functional Outcome of Site Peroneus Longus Graft Donors With and Without Distal Stump Suturing of Peroneus Tendon Brevis on ACL Reconstruction Case .

Injury of the Anterior Cruciate Ligament (ACL) is one of the most common sports injuries. The incidence rate reaches 68.6 cases per 100,000 people per year. Management of ACL injuries for individuals who want to return to the level of exercise activity as before, mostly in the form of reconstructive surgery. As many as 60,000 to 175,000 cases of ACL reconstruction per year are carried out in the United States At present, many reconstructive surgeries are performed by taking tendon grafts on the patient's own body (autograft) to then be used instead of the ACL. The most widely used graft sources are Hamstring and Bone-Patellar Tendon-Bone (BPTB) grafts. Other alternative grafts are Quadriceps tendon, Fascia Lata, Iliotibial Band, and Peroneus Longus Tendon. Each graft retrieval technique has advantages and disadvantages. BPTB graft has the best tensile strength and bone union with bone, but the complications of anterior knee pain are also quite common (5-55%). Hamstring grafts and Quadriceps grafts minimize the complications of anterior knee pain, with fairly good tensile strength, but the union of grafts with bone takes longer. The loss of Hamstring tendons also causes a decrease in muscle strength in Hamstring, where Hamstring has an important role in preventing the anterior translation of the tibia Peroneus Longus Tendon graft is an alternative graft developed to minimize complications associated with graft use from the area around the knee. Peroneus Longus tendons also have tensile strength similar to Hamstring tendons.

As with other graft extracts, Peroneus Longus tendon graft is also accompanied by complications in the donor site. Possible complications arising from the loss of the Peroneus Longus tendon include ankle instability and decreased flexion strength of the 1st ray and ankle eversion. Research carried out by Bancha et al showed a reduction in flexion strength of 1st ray and ankle eversion significantly, without any instability in the ankle. Peroneus longus provides 5.5% strength for moderate dorsiflexion for ankle eversion movements, peroneus longus is the main muscle. But in other studies it is said that the use of peroneus longus graft does not interfere with the stability of the ankle and ROM. Does not even affect the functional outcome of the ankle However, in a study conducted by Bancha et al and Kerimoglu et al., The technique used for taking Peroneus Longus graft tendons did not include suturing in the distal stump of Peroneous Longus. So with this study, researchers wanted to find out whether different results would be found related to donor site complications if the technique used included suturing the distal stump of the Peroneus Longus tendon against the peroneus brevis tendon

Conditions: Rupture of Anterior Cruciate Ligament
Being tested: Distal Stump Suturing
Keywords: ACL, Rupture of ACL, Donor site, Peroneus Longus Graft, Distal Stump, Peroneus Brevis
Medical subject headings: Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Distal Stump SuturingProcedure or surgery
in ACL Reconstruction case , Group A consist of subject with operation procedure suturing the distal stump peroneus longus against the peroneus brevis in ACL reconstruction using the peroneus longus autograft.

Study groups in NCT04431063
Study group	Role	What they receive
Sutured Stump	Experimental	The group consist of subject with distal stump suturing of perobeus longus agains peroneus brevis in ACL Reconstruction Case Receives: Procedure: Distal Stump Suturing
Unsutured Stump	No intervention	The group consist of subject without distal stump suturing of peroneus longus agains peroneus brevis in ACL Reconstruction Case

What is being measured

The primary outcome is the main question the study is designed to answer.

Preoperative hand dynamometer value
Value of objective measurement of the strength of the medial part of the plantarflexion in the one metatarsal head with the hand of the Dynamometer when the patient is supine. The measurement is done 3 times and the value used is the average of the 3 times the measurement. Healthy ankles were also examined as a comparison with the same measurement method. There is no minimum and maximum value, and the higher value the better the outcome
Measured: This measurement was carried out at the preoperative setting
Three-months postoperative hand dynamometer value
Value of objective measurement of the strength of the medial part of the plantarflexion in the one metatarsal head with the hand of the Dynamometer when the patient is supine. The measurement is done 3 times and the value used is the average of the 3 times the measurement. Healthy ankles were also examined as a comparison with the same measurement method. There is no minimum and maximum value, and the higher value the better the outcome
Measured: This measurement was carried out at 3 months postoperatively
Six-months postoperative hand dynamometer value
Value of objective measurement of the strength of the medial part of the plantarflexion in the one metatarsal head with the hand of the Dynamometer when the patient is supine. The measurement is done 3 times and the value used is the average of the 3 times the measurement. Healthy ankles were also examined as a comparison with the same measurement method. There is no minimum and maximum value, and the higher value the better the outcome
Measured: This measurement was carried out at 6 months postoperatively
Preoperative Clark's Angle Value
the value of the objective angle measurement on the footprint by drawing a line from the medial side of the one metatarsal head and the heel against the second line which is connecting the one metatrsal head and the peak of the medial longitudinal arch. Clarke Angle of < 31° means there is tendency to flatness and/or pronation. angle of 31° to < 45° is the normal range. Clarke Angle of > 45° means there is tendency to cavus foot
Measured: This measurement was carried out at the preoperative setting
Three-months Clark's Angle Value
the value of the objective angle measurement on the footprint by drawing a line from the medial side of the one metatarsal head and the heel against the second line which is connecting the one metatrsal head and the peak of the medial longitudinal arch. Clarke Angle of < 31° means there is tendency to flatness and/or pronation. angle of 31° to < 45° is the normal range. Clarke Angle of > 45° means there is tendency to cavus foot
Measured: This measurement was carried out at the 3 months postoperatively
Six-months Clark's Angle Value
the value of the objective angle measurement on the footprint by drawing a line from the medial side of the one metatarsal head and the heel against the second line which is connecting the one metatrsal head and the peak of the medial longitudinal arch. Clarke Angle of < 31° means there is tendency to flatness and/or pronation. angle of 31° to < 45° is the normal range. Clarke Angle of > 45° means there is tendency to cavus foot
Measured: This measurement was carried out at the 6 months postoperatively
Preoperative the American Orthopedic Foot and Ankle Score (AOFAS)
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AOFAS score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Measured: Examination carried out 4 times for each patient in preoperative setting
Three months postoperative the American Orthopedic Foot and Ankle Score (AOFAS)
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AOFAS score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Measured: Examination carried out 4 times for each patient in 3 months postoperatively
Six months postoperative the American Orthopedic Foot and Ankle Score (AOFAS)
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AOFAS score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Measured: Examination carried out 4 times for each patient in 6 months postoperatively
Preoperative visual analogue scale foot and ankle (VAS-FA)
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. VAS-FA score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Measured: Examination carried out 4 times for each patient at preoperative setting
Three-months postoperative visual analogue scale foot and ankle (VAS-FA)
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AS-FA score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Measured: Examination carried out 4 times for each patient at 3 months postoperatively
Six-months postoperative visual analogue scale foot and ankle (VAS-FA)
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AS-FA score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Measured: Examination carried out 4 times for each patient at 6 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201830 Jun 2022

First posted16 Jun 2020
Study start1 Dec 2018
Primary completion1 Dec 2021
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (31)Papers the sponsor has linked to this study.
Other trials for Rupture of Anterior Cruciate LigamentStudies of the same condition, open and under way.
More trials run by Universitas IndonesiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04431063
Sponsor's protocol ID: 18-10-1173
Status last verified: May 2023
First submitted: 3 Jun 2020
Last updated: 23 May 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Lyman S, Koulouvaris P, Sherman S, Do H, Mandl LA, Marx RG. Epidemiology of anterior cruciate ligament reconstruction: trends, readmissions, and subsequent knee surgery. J Bone Joint Surg Am. 2009 Oct;91(10):2321-8. doi: 10.2106/JBJS.H.00539.
PubMed 19797565
Angthong C, Chernchujit B, Apivatgaroon A, Chaijenkit K, Nualon P, Suchao-in K. The Anterior Cruciate Ligament Reconstruction with the Peroneus Longus Tendon: A Biomechanical and Clinical Evaluation of the Donor Ankle Morbidity. J Med Assoc Thai. 2015 Jun;98(6):555-60.
PubMed 26219159
Cerulli G, Placella G, Sebastiani E, Tei MM, Speziali A, Manfreda F. ACL Reconstruction: Choosing the Graft. Joints. 2013 Jun 12;1(1):18-24. eCollection 2013 Mar.
PubMed 25606507
Kerimoglu S, Aynaci O, Saracoglu M, Aydin H, Turhan AU. [Anterior cruciate ligament reconstruction with the peroneus longus tendon]. Acta Orthop Traumatol Turc. 2008 Jan-Feb;42(1):38-43. doi: 10.3944/aott.2008.038. Turkish.
PubMed 18354276
Silver RL, de la Garza J, Rang M. The myth of muscle balance. A study of relative strengths and excursions of normal muscles about the foot and ankle. J Bone Joint Surg Br. 1985 May;67(3):432-7. doi: 10.1302/0301-620X.67B3.3997956.
PubMed 3997956
Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med. 2010 Jul 22;363(4):331-42. doi: 10.1056/NEJMoa0907797.
PubMed 20660401
Mentiplay BF, Perraton LG, Bower KJ, Adair B, Pua YH, Williams GP, McGaw R, Clark RA. Assessment of Lower Limb Muscle Strength and Power Using Hand-Held and Fixed Dynamometry: A Reliability and Validity Study. PLoS One. 2015 Oct 28;10(10):e0140822. doi: 10.1371/journal.pone.0140822. eCollection 2015.
PubMed 26509265
Click Fenter P, Bellew JW, Pitts T, Kay R. A comparison of 3 hand-held dynamometers used to measure hip abduction strength. J Strength Cond Res. 2003 Aug;17(3):531-5. doi: 10.1519/1533-4287(2003)0172.0.co;2.
PubMed 12930182
Surburg PR, Suomi R, Poppy WK. Validity and reliability of a hand-held dynamometer with two populations. J Orthop Sports Phys Ther. 1992;16(5):229-34. doi: 10.2519/jospt.1992.16.5.229.
PubMed 18796754
Murley GS, Tan JM, Edwards RM, De Luca J, Munteanu SE, Cook JL. Foot posture is associated with morphometry of the peroneus longus muscle, tibialis anterior tendon, and Achilles tendon. Scand J Med Sci Sports. 2014 Jun;24(3):535-41. doi: 10.1111/sms.12025. Epub 2013 Jan 10.
PubMed 23301865
Pita-Fernandez S, Gonzalez-Martin C, Seoane-Pillado T, Lopez-Calvino B, Pertega-Diaz S, Gil-Guillen V. Validity of footprint analysis to determine flatfoot using clinical diagnosis as the gold standard in a random sample aged 40 years and older. J Epidemiol. 2015;25(2):148-54. doi: 10.2188/jea.JE20140082. Epub 2014 Nov 8.
PubMed 25382154
Gonzalez-Martin C, Pita-Fernandez S, Seoane-Pillado T, Lopez-Calvino B, Pertega-Diaz S, Gil-Guillen V. Variability between Clarke's angle and Chippaux-Smirak index for the diagnosis of flat feet. Colomb Med (Cali). 2017 Mar 30;48(1):25-31.
PubMed 28559643
Quatman CE, Hewett TE. The anterior cruciate ligament injury controversy: is "valgus collapse" a sex-specific mechanism? Br J Sports Med. 2009 May;43(5):328-35. doi: 10.1136/bjsm.2009.059139. Epub 2009 Apr 15.
PubMed 19372087
McGuine TA, Winterstein AP, Carr K, Hetzel S. Changes in Health-Related Quality of Life and Knee Function After Knee Injury in Young Female Athletes. Orthop J Sports Med. 2014 Apr 22;2(4):2325967114530988. doi: 10.1177/2325967114530988. eCollection 2014 Apr.
PubMed 26535324
Beynnon BD, Johnson RJ, Abate JA, Fleming BC, Nichols CE. Treatment of anterior cruciate ligament injuries, part I. Am J Sports Med. 2005 Oct;33(10):1579-602. doi: 10.1177/0363546505279913.
PubMed 16199611

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruitingPhase 3
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Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
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Osteoarthritis, Knee, Post-traumatic Osteoarthritis

All Rupture of Anterior Cruciate Ligament trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Functional Outcome of Site Peroneus Longus Graft Donors With and Without Distal Stump Suturing of Peroneus Tendon Brevis on ACL Reconstruction Case .
ClinicalTrials.gov ID: NCT04431063
Acronym / sponsor ID: 18-10-1173
Conditions: Rupture of Anterior Cruciate Ligament
Keywords: ACL, Rupture of ACL, Donor site, Peroneus Longus Graft, Distal Stump, Peroneus Brevis
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Universitas IndonesiaUniversity, hospital or other
Study start: 1 Dec 2018 (actual)
Primary completion: 1 Dec 2021 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 16 Jun 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sutured Stump	Experimental	Procedure: Distal Stump SuturingThe group consist of subject with distal stump suturing of perobeus longus agains peroneus brevis in ACL Reconstruction Case
Unsutured Stump	No intervention	–The group consist of subject without distal stump suturing of peroneus longus agains peroneus brevis in ACL Reconstruction Case

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Patients with total ACL rupture using peroneus longus graft
The suturing procedure for the distal stump peroneus longus against the peroneus brevis tendon is performed by orthopedic specialists or resident chiefs who have been given training in advance.

Key exclusion criteria (3 listed)

Osteoarthtis Knee Kellgren-Lawrence III and IV
Osteoarthtis Knee Kellgren-Lawrence III and IV
Flatfoot as evidenced by physical examination and footprinting

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Distal Stump Suturingin ACL Reconstruction case , Group A consist of subject with operation procedure suturing the distal stump peroneus longus against the peroneus brevis in ACL reconstruction using the peroneus longus autograft.	Procedure or surgery	Sutured Stump

Primary outcome

Preoperative hand dynamometer value
Time frame: This measurement was carried out at the preoperative setting
Value of objective measurement of the strength of the medial part of the plantarflexion in the one metatarsal head with the hand of the Dynamometer when the patient is supine. The measurement is done 3 times and the value used is the average of the 3 times the measurement. Healthy ankles were also examined as a comparison with the same measurement method. There is no minimum and maximum value, and the higher value the better the outcome
Three-months postoperative hand dynamometer value
Time frame: This measurement was carried out at 3 months postoperatively
Value of objective measurement of the strength of the medial part of the plantarflexion in the one metatarsal head with the hand of the Dynamometer when the patient is supine. The measurement is done 3 times and the value used is the average of the 3 times the measurement. Healthy ankles were also examined as a comparison with the same measurement method. There is no minimum and maximum value, and the higher value the better the outcome
Six-months postoperative hand dynamometer value
Time frame: This measurement was carried out at 6 months postoperatively
Value of objective measurement of the strength of the medial part of the plantarflexion in the one metatarsal head with the hand of the Dynamometer when the patient is supine. The measurement is done 3 times and the value used is the average of the 3 times the measurement. Healthy ankles were also examined as a comparison with the same measurement method. There is no minimum and maximum value, and the higher value the better the outcome
Preoperative Clark's Angle Value
Time frame: This measurement was carried out at the preoperative setting
the value of the objective angle measurement on the footprint by drawing a line from the medial side of the one metatarsal head and the heel against the second line which is connecting the one metatrsal head and the peak of the medial longitudinal arch. Clarke Angle of < 31° means there is tendency to flatness and/or pronation. angle of 31° to < 45° is the normal range. Clarke Angle of > 45° means there is tendency to cavus foot
Three-months Clark's Angle Value
Time frame: This measurement was carried out at the 3 months postoperatively
the value of the objective angle measurement on the footprint by drawing a line from the medial side of the one metatarsal head and the heel against the second line which is connecting the one metatrsal head and the peak of the medial longitudinal arch. Clarke Angle of < 31° means there is tendency to flatness and/or pronation. angle of 31° to < 45° is the normal range. Clarke Angle of > 45° means there is tendency to cavus foot
Six-months Clark's Angle Value
Time frame: This measurement was carried out at the 6 months postoperatively
the value of the objective angle measurement on the footprint by drawing a line from the medial side of the one metatarsal head and the heel against the second line which is connecting the one metatrsal head and the peak of the medial longitudinal arch. Clarke Angle of < 31° means there is tendency to flatness and/or pronation. angle of 31° to < 45° is the normal range. Clarke Angle of > 45° means there is tendency to cavus foot
Preoperative the American Orthopedic Foot and Ankle Score (AOFAS)
Time frame: Examination carried out 4 times for each patient in preoperative setting
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AOFAS score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Three months postoperative the American Orthopedic Foot and Ankle Score (AOFAS)
Time frame: Examination carried out 4 times for each patient in 3 months postoperatively
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AOFAS score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Six months postoperative the American Orthopedic Foot and Ankle Score (AOFAS)
Time frame: Examination carried out 4 times for each patient in 6 months postoperatively
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AOFAS score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Preoperative visual analogue scale foot and ankle (VAS-FA)
Time frame: Examination carried out 4 times for each patient at preoperative setting
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. VAS-FA score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Three-months postoperative visual analogue scale foot and ankle (VAS-FA)
Time frame: Examination carried out 4 times for each patient at 3 months postoperatively
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AS-FA score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
Six-months postoperative visual analogue scale foot and ankle (VAS-FA)
Time frame: Examination carried out 4 times for each patient at 6 months postoperatively
the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AS-FA score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
Background: PubMed 19797565Lyman S, Koulouvaris P, Sherman S, Do H, Mandl LA, Marx RG. Epidemiology of anterior cruciate ligament reconstruction: trends, readmissions, and subsequent knee surgery. J Bone Joint Surg Am. 2009 Oct;91(10):2321-8. doi: 10.2106/JBJS.H.00539.
Background: PubMed 26219159Angthong C, Chernchujit B, Apivatgaroon A, Chaijenkit K, Nualon P, Suchao-in K. The Anterior Cruciate Ligament Reconstruction with the Peroneus Longus Tendon: A Biomechanical and Clinical Evaluation of the Donor Ankle Morbidity. J Med Assoc Thai. 2015 Jun;98(6):555-60.
Background: PubMed 25606507Cerulli G, Placella G, Sebastiani E, Tei MM, Speziali A, Manfreda F. ACL Reconstruction: Choosing the Graft. Joints. 2013 Jun 12;1(1):18-24. eCollection 2013 Mar.
Background: PubMed 18354276Kerimoglu S, Aynaci O, Saracoglu M, Aydin H, Turhan AU. [Anterior cruciate ligament reconstruction with the peroneus longus tendon]. Acta Orthop Traumatol Turc. 2008 Jan-Feb;42(1):38-43. doi: 10.3944/aott.2008.038. Turkish.
Background: PubMed 3997956Silver RL, de la Garza J, Rang M. The myth of muscle balance. A study of relative strengths and excursions of normal muscles about the foot and ankle. J Bone Joint Surg Br. 1985 May;67(3):432-7. doi: 10.1302/0301-620X.67B3.3997956.
Background: PubMed 20660401Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med. 2010 Jul 22;363(4):331-42. doi: 10.1056/NEJMoa0907797.
Background: PubMed 26509265Mentiplay BF, Perraton LG, Bower KJ, Adair B, Pua YH, Williams GP, McGaw R, Clark RA. Assessment of Lower Limb Muscle Strength and Power Using Hand-Held and Fixed Dynamometry: A Reliability and Validity Study. PLoS One. 2015 Oct 28;10(10):e0140822. doi: 10.1371/journal.pone.0140822. eCollection 2015.
Background: PubMed 12930182Click Fenter P, Bellew JW, Pitts T, Kay R. A comparison of 3 hand-held dynamometers used to measure hip abduction strength. J Strength Cond Res. 2003 Aug;17(3):531-5. doi: 10.1519/1533-4287(2003)0172.0.co;2.
Background: PubMed 18796754Surburg PR, Suomi R, Poppy WK. Validity and reliability of a hand-held dynamometer with two populations. J Orthop Sports Phys Ther. 1992;16(5):229-34. doi: 10.2519/jospt.1992.16.5.229.
Background: PubMed 23301865Murley GS, Tan JM, Edwards RM, De Luca J, Munteanu SE, Cook JL. Foot posture is associated with morphometry of the peroneus longus muscle, tibialis anterior tendon, and Achilles tendon. Scand J Med Sci Sports. 2014 Jun;24(3):535-41. doi: 10.1111/sms.12025. Epub 2013 Jan 10.
Background: PubMed 25382154Pita-Fernandez S, Gonzalez-Martin C, Seoane-Pillado T, Lopez-Calvino B, Pertega-Diaz S, Gil-Guillen V. Validity of footprint analysis to determine flatfoot using clinical diagnosis as the gold standard in a random sample aged 40 years and older. J Epidemiol. 2015;25(2):148-54. doi: 10.2188/jea.JE20140082. Epub 2014 Nov 8.
Background: PubMed 28559643Gonzalez-Martin C, Pita-Fernandez S, Seoane-Pillado T, Lopez-Calvino B, Pertega-Diaz S, Gil-Guillen V. Variability between Clarke's angle and Chippaux-Smirak index for the diagnosis of flat feet. Colomb Med (Cali). 2017 Mar 30;48(1):25-31.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Distal Stump Suturing in people with Rupture of Anterior Cruciate Ligament, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preoperative hand dynamometer value (time frame: This measurement was carried out at the preoperative setting). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04431063, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.