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Anterior Cruciate Ligament InjuryNCT07762989

Donor Ankle Sensorimotor Recovery After ACL Reconstruction With a Peroneus Longus Tendon Autograft

An observational study of Anterior Cruciate Ligament Injury and Anterior Cruciate Ligament Reconstruction, run by Gazi University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This prospective longitudinal observational cohort study will characterize recovery of donor-ankle sensorimotor function in adults who have undergone primary anterior cruciate ligament reconstruction using a peroneus longus tendon autograft. Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
Anterior Cruciate Ligament Reconstruction Using a Peroneus Longus Tendon Autograft
Type of treatment
Surgery or procedure
How many people
20 participants
Where
1 siteTurkey (Türkiye)
Study dates
22 Aug 2026to 1 Oct 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Adults aged 18 to 55 years who have undergone primary unilateral anterior cruciate ligament reconstruction using a peroneus longus tendon autograft as part of routine clinical care and are referred to the Sports Health Unit, Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi University, for postoperative rehabilitation and functional assessment. Eligible participants will be enrolled consecutively during the study period.

Who may be able to join

  • Age 18 to 55 years.
  • Unilateral primary anterior cruciate ligament tear confirmed by clinical examination and magnetic resonance imaging.
  • Primary anterior cruciate ligament reconstruction performed using a peroneus longus tendon autograft.
  • Able and willing to attend the postoperative assessments at 6-8 weeks, 3 months, and 6 months.
  • Written informed consent provided before study participation.

Who cannot join

  • Multiligament knee injury.
  • Previous surgery on the index knee or donor ankle.
  • Pre-existing ankle instability or major foot or ankle pathology.
  • Neurological or neuromuscular disease.
  • Inflammatory or systemic disease that may affect the assessments.
  • Major lower-extremity deformity that may affect the assessments.
  • Unable to complete the postoperative rehabilitation program or scheduled follow-up assessments.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dudu Ozdemir Can, Msc contact

+90 5534448492

duduozdemir@gazi.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Sports Health Unit

    Çankaya, Ankara, 06490

    Dudu Ozdemir Can, MSc, +90 5534448492, duduozdemir@gazi.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Recovery of Donor Ankle Sensorimotor Function Following Anterior Cruciate Ligament Reconstruction Using Peroneus Longus Tendon Autograft: A Prospective Longitudinal Study

This prospective longitudinal observational cohort study will characterize recovery of donor-ankle sensorimotor function in adults who have undergone primary anterior cruciate ligament reconstruction using a peroneus longus tendon autograft. Twenty participants aged 18 to 55 years will be evaluated at postoperative 6-8 weeks, 3 months, and 6 months. The donor limb and the contralateral non-donor limb will be compared using surface electromyography of the peroneus longus, force-platform measures of postural control, inertial-sensor gait analysis, active ankle joint-position sense testing, and clinical and patient-reported foot and ankle function measures. The study does not assign the surgical procedure or rehabilitation treatment.

Read the detailed description

Peroneus longus tendon autograft is used as an alternative graft source for anterior cruciate ligament reconstruction, but the longitudinal course of donor-site sensorimotor recovery has not been sufficiently described with objective measures. This study is designed to examine within-participant changes over time and differences between the donor and contralateral non-donor limbs.

Eligible participants who underwent primary unilateral anterior cruciate ligament reconstruction with a peroneus longus tendon autograft at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital or Halil Şıvgın Çubuk State Hospital and who are referred to the Sports Health Unit of Gazi University will be followed at postoperative 6-8 weeks, 3 months, and 6 months. No graft type, surgery, or rehabilitation intervention is assigned by the investigators.

At each assessment, peroneus longus activation will be recorded during single-leg heel-rise and medially inclined heel-rise tasks using surface electromyography and normalized to a session-specific maximal voluntary isometric contraction. Postural control will be assessed with KFORCE Plates during double-leg and single-leg balance tasks. Spatiotemporal gait and pelvic kinematics will be recorded with the G-Walk inertial sensor system. Active ankle joint-position sense will be assessed on a Cybex NORM dynamometer using a 15-degree eversion target. Foot and ankle function will be assessed using the Foot and Ankle Ability Measure.

The primary analysis will examine time, limb, and time-by-limb effects across the three postoperative assessments. Parametric data will be analyzed using two-way repeated-measures analysis of variance, with nonparametric alternatives used when assumptions are not met. The planned enrollment is 20 participants, allowing for approximately 20% attrition from the minimum required sample of 16 completers.

Being tested
Anterior Cruciate Ligament Reconstruction Using a Peroneus Longus Tendon Autograft
Keywords
peroneus longus tendon autograft, donor ankle, sensorimotor function, surface electromyography, postural control, proprioception, gait analysis
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.

  • Anterior Cruciate Ligament Reconstruction Using a Peroneus Longus Tendon AutograftProcedure or surgery

    Participants undergo primary anterior cruciate ligament reconstruction using a peroneus longus tendon autograft as part of their routine clinical care. The graft choice and surgical procedure are determined by the treating orthopedic surgeon independently of study participation. The study does not assign or modify the graft choice, surgical technique, or postoperative rehabilitation. Participants receive routine postoperative rehabilitation according to their clinical needs, while donor-ankle sensorimotor recovery is assessed prospectively at 6-8 weeks, 3 months, and 6 months after surgery.

Study groups in NCT07762989
Study groupRoleWhat they receive
Peroneus Longus Tendon Autograft ACLR CohortAdults after primary unilateral ACL reconstruction using a peroneus longus tendon autograft. Participants will undergo observational assessments at postoperative 6-8 weeks, 3 months, and 6 months. Donor-limb measures will be compared with measurements from the contralateral non-donor limb. No intervention is assigned by the study.
Receives: Procedure: Anterior Cruciate Ligament Reconstruction Using a Peroneus Longus Tendon Autograft

What is being measured

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

  1. Change in Mean Center of Pressure Velocity During Single-Leg Balance

    Mean center of pressure (CoP) velocity during a 10-second single-leg stance, assessed separately with eyes open and eyes closed on KFORCE Plates. Each limb will be tested in three trials, and the mean for each condition will be used. Values are expressed in millimeters per second (mm/s); lower values indicate less postural sway. Change from the postoperative 6-8-week assessment to 3 and 6 months and donor-versus-contralateral limb differences will be evaluated.

    Measured: Postoperative 6-8 weeks, 3 months, and 6 months

Secondary outcomes (18)
  1. Change in CoP Path Length During Single-Leg Balance

    Total CoP path length during a 10-second single-leg stance with eyes open and eyes closed on KFORCE Plates, averaged across three valid trials for each limb and condition. Unit: millimeters (mm); lower values indicate less sway.

    Measured: Postoperative 6-8 weeks, 3 months, and 6 months

  2. Change in CoP Ellipse Area During Single-Leg Balance

    Ellipse area of CoP excursion during a 10-second single-leg stance with eyes open and eyes closed on KFORCE Plates, averaged across three valid trials. Unit: square millimeters (mm²); lower values indicate less sway area.

    Measured: Postoperative 6-8 weeks, 3 months, and 6 months

  3. Change in Mean CoP Velocity During Double-Leg Balance

    Mean CoP velocity during 30-second double-leg quiet stance with eyes open and eyes closed on KFORCE Plates, averaged across three trials per condition. Unit: millimeters per second (mm/s).

    Measured: Postoperative 6-8 weeks, 3 months, and 6 months

  4. Change in CoP Path Length During Double-Leg Balance

    Total CoP path length during 30-second double-leg quiet stance with eyes open and eyes closed on KFORCE Plates, averaged across three trials per condition. Unit: millimeters (mm).

    Measured: Postoperative 6-8 weeks, 3 months, and 6 months

  5. Change in CoP Ellipse Area During Double-Leg Balance

    Ellipse area of CoP excursion during 30-second double-leg quiet stance with eyes open and eyes closed on KFORCE Plates, averaged across three trials per condition. Unit: square millimeters (mm²).

    Measured: Postoperative 6-8 weeks, 3 months, and 6 months

  6. Change in Mean Normalized Peroneus Longus RMS Amplitude During Single-Leg Heel Rise

    Mean root-mean-square surface EMG amplitude of the peroneus longus during the concentric, isometric, and eccentric phases of a metronome-paced single-leg heel rise. Each phase is reported separately as a percentage of session-specific maximal voluntary isometric contraction (%MVIC), averaged across three repetitions for each limb.

    Measured: Postoperative 6-8 weeks, 3 months, and 6 months

  7. Change in Peak Normalized Peroneus Longus RMS Amplitude During Single-Leg Heel Rise

    Peak root-mean-square surface EMG amplitude during the concentric, isometric, and eccentric phases of a single-leg heel rise. Each phase is reported separately as %MVIC and averaged across three repetitions for each limb.

    Measured: Postoperative 6-8 weeks, 3 months, and 6 months

  8. Change in Mean Normalized Peroneus Longus RMS Amplitude During Incline Heel Rise

    Mean root-mean-square surface EMG amplitude during the concentric, isometric, and eccentric phases of a single-leg heel rise on a rigid platform with approximately 30 degrees of medial inclination. Each phase is reported separately as %MVIC and averaged across three repetitions for each limb.

    Measured: Postoperative 6-8 weeks, 3 months, and 6 months

  9. Change in Peak Normalized Peroneus Longus RMS Amplitude During Incline Heel Rise

    Peak root-mean-square surface EMG amplitude during the concentric, isometric, and eccentric phases of the medially inclined single-leg heel-rise task. Each phase is reported separately as %MVIC and averaged across three repetitions for each limb.

    Measured: Postoperative 6-8 weeks, 3 months, and 6 months

  10. Change in Ankle Joint Position Sense Absolute Error

    Absolute difference between the 15-degree eversion target and the angle reproduced by the participant during active joint-position sense testing with eyes closed on a Cybex NORM dynamometer. Each limb will be evaluated separately. Unit: degrees (°); lower values indicate greater position-sense accuracy.

    Measured: Postoperative 6-8 weeks, 3 months, and 6 months

  11. Change in Self-Selected Gait Speed

    Walking speed recorded with the G-Walk inertial sensor during self-selected walking over an approximately 10-meter walkway. The middle portion of the walk will be analyzed and three trials will be averaged. Unit: meters per second (m/s).

    Measured: Postoperative 6-8 weeks, 3 months, and 6 months

  12. Change in Gait Cadence

    Cadence recorded with the G-Walk inertial sensor during self-selected walking, averaged across three trials. Unit: steps per minute.

    Measured: Postoperative 6-8 weeks, 3 months, and 6 months

  13. Change in Step Length

    Step length recorded with the G-Walk inertial sensor during self-selected walking, averaged across three trials. Unit: meters (m).

    Measured: Postoperative 6-8 weeks, 3 months, and 6 months

  14. Change in Gait Symmetry Index

    Between-limb gait symmetry index derived from G-Walk spatiotemporal data. Unit: percent (%); values closer to the device-defined symmetry reference indicate greater symmetry.

    Measured: Postoperative 6-8 weeks, 3 months, and 6 months

  15. Change in Pelvic Tilt During Gait

    Sagittal-plane pelvic tilt measured by the G-Walk inertial sensor during self-selected walking, averaged across three trials. Unit: degrees (°).

    Measured: Postoperative 6-8 weeks, 3 months, and 6 months

  16. Change in Pelvic Obliquity During Gait

    Frontal-plane pelvic obliquity measured by the G-Walk inertial sensor during self-selected walking, averaged across three trials. Unit: degrees (°).

    Measured: Postoperative 6-8 weeks, 3 months, and 6 months

  17. Change in FAAM Activities of Daily Living Subscale

    Foot and Ankle Ability Measure Activities of Daily Living subscale, transformed to a 0%-100% score. Higher percentages indicate better self-reported function.

    Measured: Preoperative, Postoperative 6-8 weeks, 3 months, and 6 months

  18. Change in FAAM Sports Subscale

    Foot and Ankle Ability Measure Sports subscale, transformed to a 0%-100% score. Higher percentages indicate better self-reported sport-related function.

    Measured: Preoperative, Postoperative 6-8 weeks, 3 months, and 6 months

Timeline

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

  1. First posted13 Aug 2026
  2. Study start22 Aug 2026
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07762989
Sponsor's protocol ID
2026-1435
Status last verified
Oct 2026
First submitted
10 Aug 2026
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data sharing plan has been specified for this study.

Questions about this trial

What is this clinical trial studying?

An observational study of Anterior Cruciate Ligament Injury and Anterior Cruciate Ligament Reconstruction, run by Gazi University at 1 site in Turkey (Türkiye).

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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. 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 Turkey (Türkiye). 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Dudu Ozdemir Can, Msc (+90 5534448492, duduozdemir@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mean Center of Pressure Velocity During Single-Leg Balance (time frame: Postoperative 6-8 weeks, 3 months, and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 9 Oct 2026.

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