- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07762989
Donor Ankle Sensorimotor Recovery After ACL Reconstruction With a Peroneus Longus Tendon Autograft
Recovery of Donor Ankle Sensorimotor Function Following Anterior Cruciate Ligament Reconstruction Using Peroneus Longus Tendon Autograft: A Prospective Longitudinal Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Dudu Ozdemir Can, MSc
- Phone Number: +90 5534448492
- Email: duduozdemir@gazi.edu.tr
Study Locations
-
-
Ankara
-
Çankaya, Ankara, Turkey (Türkiye), 06490
- Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Sports Health Unit
-
Contact:
- Dudu Ozdemir Can, MSc
- Phone Number: +90 5534448492
- Email: duduozdemir@gazi.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Peroneus Longus Tendon Autograft ACLR Cohort
Adults 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Mean Center of Pressure Velocity During Single-Leg Balance
Time Frame: Postoperative 6-8 weeks, 3 months, and 6 months
|
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.
|
Postoperative 6-8 weeks, 3 months, and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in CoP Path Length During Single-Leg Balance
Time Frame: Postoperative 6-8 weeks, 3 months, and 6 months
|
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.
|
Postoperative 6-8 weeks, 3 months, and 6 months
|
|
Change in CoP Ellipse Area During Single-Leg Balance
Time Frame: Postoperative 6-8 weeks, 3 months, and 6 months
|
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.
|
Postoperative 6-8 weeks, 3 months, and 6 months
|
|
Change in Mean CoP Velocity During Double-Leg Balance
Time Frame: Postoperative 6-8 weeks, 3 months, and 6 months
|
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).
|
Postoperative 6-8 weeks, 3 months, and 6 months
|
|
Change in CoP Path Length During Double-Leg Balance
Time Frame: Postoperative 6-8 weeks, 3 months, and 6 months
|
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).
|
Postoperative 6-8 weeks, 3 months, and 6 months
|
|
Change in CoP Ellipse Area During Double-Leg Balance
Time Frame: Postoperative 6-8 weeks, 3 months, and 6 months
|
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).
|
Postoperative 6-8 weeks, 3 months, and 6 months
|
|
Change in Mean Normalized Peroneus Longus RMS Amplitude During Single-Leg Heel Rise
Time Frame: Postoperative 6-8 weeks, 3 months, and 6 months
|
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.
|
Postoperative 6-8 weeks, 3 months, and 6 months
|
|
Change in Peak Normalized Peroneus Longus RMS Amplitude During Single-Leg Heel Rise
Time Frame: Postoperative 6-8 weeks, 3 months, and 6 months
|
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.
|
Postoperative 6-8 weeks, 3 months, and 6 months
|
|
Change in Mean Normalized Peroneus Longus RMS Amplitude During Incline Heel Rise
Time Frame: Postoperative 6-8 weeks, 3 months, and 6 months
|
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.
|
Postoperative 6-8 weeks, 3 months, and 6 months
|
|
Change in Peak Normalized Peroneus Longus RMS Amplitude During Incline Heel Rise
Time Frame: Postoperative 6-8 weeks, 3 months, and 6 months
|
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.
|
Postoperative 6-8 weeks, 3 months, and 6 months
|
|
Change in Ankle Joint Position Sense Absolute Error
Time Frame: Postoperative 6-8 weeks, 3 months, and 6 months
|
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.
|
Postoperative 6-8 weeks, 3 months, and 6 months
|
|
Change in Self-Selected Gait Speed
Time Frame: Postoperative 6-8 weeks, 3 months, and 6 months
|
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).
|
Postoperative 6-8 weeks, 3 months, and 6 months
|
|
Change in Gait Cadence
Time Frame: Postoperative 6-8 weeks, 3 months, and 6 months
|
Cadence recorded with the G-Walk inertial sensor during self-selected walking, averaged across three trials.
Unit: steps per minute.
|
Postoperative 6-8 weeks, 3 months, and 6 months
|
|
Change in Step Length
Time Frame: Postoperative 6-8 weeks, 3 months, and 6 months
|
Step length recorded with the G-Walk inertial sensor during self-selected walking, averaged across three trials.
Unit: meters (m).
|
Postoperative 6-8 weeks, 3 months, and 6 months
|
|
Change in Gait Symmetry Index
Time Frame: Postoperative 6-8 weeks, 3 months, and 6 months
|
Between-limb gait symmetry index derived from G-Walk spatiotemporal data.
Unit: percent (%); values closer to the device-defined symmetry reference indicate greater symmetry.
|
Postoperative 6-8 weeks, 3 months, and 6 months
|
|
Change in Pelvic Tilt During Gait
Time Frame: Postoperative 6-8 weeks, 3 months, and 6 months
|
Sagittal-plane pelvic tilt measured by the G-Walk inertial sensor during self-selected walking, averaged across three trials.
Unit: degrees (°).
|
Postoperative 6-8 weeks, 3 months, and 6 months
|
|
Change in Pelvic Obliquity During Gait
Time Frame: Postoperative 6-8 weeks, 3 months, and 6 months
|
Frontal-plane pelvic obliquity measured by the G-Walk inertial sensor during self-selected walking, averaged across three trials.
Unit: degrees (°).
|
Postoperative 6-8 weeks, 3 months, and 6 months
|
|
Change in FAAM Activities of Daily Living Subscale
Time Frame: Preoperative, Postoperative 6-8 weeks, 3 months, and 6 months
|
Foot and Ankle Ability Measure Activities of Daily Living subscale, transformed to a 0%-100% score.
Higher percentages indicate better self-reported function.
|
Preoperative, Postoperative 6-8 weeks, 3 months, and 6 months
|
|
Change in FAAM Sports Subscale
Time Frame: Preoperative, Postoperative 6-8 weeks, 3 months, and 6 months
|
Foot and Ankle Ability Measure Sports subscale, transformed to a 0%-100% score.
Higher percentages indicate better self-reported sport-related function.
|
Preoperative, Postoperative 6-8 weeks, 3 months, and 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nihan Karatas, Prof. Dr., Gazi University
- Principal Investigator: Dudu Ozdemir Can, MSc, Gazi University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-1435
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.