Early Rehabilitationin in Tibial Spine Avulsion Fracture Managed With Arthoscopic Fibre Wire Fixation (ER-TSAV)

February 24, 2026 updated by: Abdul Jabbar

Tibial spine avulsion fracture is a common knee injury in adolescents and young adults, often caused by sports trauma or falls. It involves avulsion of the anterior cruciate ligament (ACL) attachment from the tibial eminence and may lead to pain, restricted range of motion, instability, and long-term functional limitations. Arthroscopic fixation using fiber wire is a widely accepted surgical technique for restoring joint stability. However, there is ongoing debate regarding the optimal timing of postoperative rehabilitation.

Traditionally, delayed rehabilitation protocols have been used to protect the surgical repair, but prolonged immobilization may lead to joint stiffness, quadriceps atrophy, delayed recovery, and prolonged return to sports. Early rehabilitation protocols aim to initiate controlled mobilization soon after surgery to enhance recovery of knee range of motion, muscle strength, and functional performance while maintaining surgical stability.

This randomized clinical trial will compare the effectiveness of early rehabilitation versus conventional (delayed) rehabilitation in patients aged 15-25 years who undergo arthroscopic fiber wire fixation for tibial spine avulsion fracture. Outcomes including knee range of motion (measured using a goniometer), muscle strength (measured using a hand-held dynamometer), and functional disability (assessed using the International Knee Documentation Committee (IKDC) Score) will be evaluated at baseline, 6 weeks, and 12 weeks postoperatively.

The findings of this study may help establish evidence-based rehabilitation guidelines and determine whether early rehabilitation provides superior functional outcomes compared to conventional therapy following tibial spine fixation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Tibial spine avulsion fractures are frequently observed in young individuals following sports injuries or traumatic falls. The injury occurs when the anterior cruciate ligament (ACL) pulls off a fragment of bone from the tibial eminence. Arthroscopic fiber wire fixation is a minimally invasive surgical technique that provides stable fixation and allows for anatomical reduction of the avulsed fragment. Despite surgical advancements, postoperative rehabilitation protocols remain controversial.

Conventional rehabilitation protocols typically emphasize prolonged immobilization and delayed initiation of knee range of motion exercises to protect the fixation. However, immobilization may lead to complications such as arthrofibrosis, quadriceps weakness, delayed neuromuscular recovery, and prolonged return to daily and sports activities. Early rehabilitation protocols propose controlled and progressive mobilization immediately after surgery to promote joint nutrition, prevent muscle atrophy, and enhance functional recovery without compromising surgical healing.

This randomized clinical trial will be conducted at the Department of Orthopedics & Sports Surgery, Jinnah Hospital, Allama Iqbal Medical College, Lahore. Eligible participants aged 15-25 years undergoing arthroscopic fiber wire fixation for tibial spine avulsion fracture will be recruited. After informed consent, participants will be randomly allocated into two groups using the lottery method:

Group A (Experimental Group): Early rehabilitation protocol beginning immediately after surgery, including controlled range of motion exercises, progressive strengthening, proprioceptive training, and gradual weight-bearing progression over 12 weeks.

Group B (Control Group): Conventional rehabilitation protocol with knee immobilization for the first 6 weeks postoperatively, followed by gradual initiation of rehabilitation.

Outcome measures include:

  • Knee Range of Motion measured using a universal goniometer
  • Muscle strength of quadriceps and hamstrings assessed using a hand-held dynamometer
  • Functional disability assessed using the International Knee Documentation Committee (IKDC) Score

Assessments will be conducted at baseline, at the end of 6 weeks, and at the end of 12 weeks postoperatively.

Data will be analyzed using SPSS version 23. Normality of data will be assessed using Kolmogorov-Smirnov and Shapiro-Wilk tests. Repeated Measures ANOVA or Friedman test will be used for within-group comparisons, while Independent t-test or Mann-Whitney U test will be applied for between-group analysis. A p-value ≤ 0.05 will be considered statistically significant.

This study aims to provide clinical evidence regarding the safety and effectiveness of early rehabilitation following arthroscopic fiber wire fixation of tibial spine avulsion fractures and may contribute to improved postoperative rehabilitation guidelines and patient outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Recruiting
        • University of Lahore Teaching Hospital, Lahore
        • Contact:
        • Contact:
        • Principal Investigator:
          • Abdul Jabbar, MSPTS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Both Gender
  • Age 15-25 Years
  • General Population
  • History of Fall,
  • Sports Activity

Exclusion Criteria:

  • Neglected Tibial Spine Avulsion Fracture for more than 6 months.
  • Polytrauma, e.g., femur fracture, tibial fracture (other than tibial spine or condylar fracture), patella fracture.
  • Multiligamentous Knee Injury, e.g., PCL injury, PLC, LCL, MCL, patellofemoral ligament (MPFL) injury, meniscus injury.
  • Other Deformative Problems, Genu Valgus, Genu Varus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: group A Early Rehabilitation After Arthroscopic Fiber Wire Fixation
Participants in this arm will receive an early rehabilitation protocol beginning immediately after arthroscopic fiber wire fixation of tibial spine avulsion fracture. Rehabilitation will start in the immediate postoperative period with controlled range of motion exercises, quadriceps and hamstring isometric strengthening, ankle pumps, and straight leg raises. The protocol will progressively advance over 12 weeks, including gradual increase in knee flexion, progressive weight bearing, resistance training, proprioceptive exercises, balance training, cycling, functional strengthening, and sport-specific drills. Range of motion, muscle strength, and functional disability (IKDC score) will be assessed at baseline, 6 weeks, and 12 weeks.
Behavioral: Early Postoperative Rehabilitation Program

The Early Postoperative Rehabilitation Program will begin immediately after arthroscopic fiber wire fixation of tibial spine avulsion fracture. During the first postoperative week, patients will perform protected exercises including ankle pumps, quadriceps isometrics, straight leg raises, and controlled active knee flexion limited to 30 degrees without resistance. The PRICE protocol (Protect, Rest, Ice, Compression, Elevation) will be applied.

From weeks 2-6, controlled progression of knee flexion (up to 90-100 degrees by week 6), gradual introduction of partial weight-bearing (up to 30%), and supervised strengthening exercises will be implemented. From weeks 7-12, rehabilitation will focus on progressive resistance training of quadriceps and hamstrings, balance an
Active Comparator: group B Conventional
Participants in this arm will follow a conventional postoperative protocol involving knee immobilization for the first 6 weeks after surgery. During this period, patients will perform basic home-based management including ankle pumps, icing, elevation, straight leg raises, and isometric exercises without active knee mobilization. Structured rehabilitation will begin after 6 weeks, focusing on gradual restoration of knee range of motion, strengthening of quadriceps and hamstrings, and progressive functional training. Outcomes will be measured at baseline, 6 weeks, and 12 weeks.
Behavioral: Conventional (Delayed) Rehabilitation Program

The Conventional Rehabilitation Program will involve knee immobilization for the first 6 postoperative weeks following arthroscopic fiber wire fixation. During this period, patients will use a knee immobilizer and perform home-based management including ankle pumps, straight leg raises, quadriceps isometric exercises, icing, leg elevation, and non-weight-bearing ambulation.

Formal rehabilitation will begin after week 6 and will include gradual restoration of knee range of motion, progressive strengthening of quadriceps and hamstrings, controlled weight-bearing progression, and functional training exercises. Advanced strengthening, proprioceptive training, and sport-specific exercises will be introduced only after adequate healing and surgeon clearance.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Knee Range of Motion (ROM)
Time Frame: Baseline (Postoperative Week 1), Week 6, and Week 12
Knee range of motion (flexion and extension) will be measured using a universal goniometer. The goniometer will be aligned with the lateral femoral epicondyle as the axis, with the stationary arm aligned with the femur and the moving arm aligned with the fibula. Active knee flexion and extension will be recorded in degrees. The primary outcome will be the change in ROM from baseline to 12 weeks postoperatively. Greater degrees of flexion and restoration of full extension indicate better recovery and improved joint mobility.
Baseline (Postoperative Week 1), Week 6, and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abdul Jabbar

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Abdul Jabbar, MSPTS, The University of Lahore, Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 27, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UOL/IREB/25/15/03/07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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