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Recruiting NCT07428291

Early Rehabilitationin in Tibial Spine Avulsion Fracture Managed With Arthoscopic Fibre Wire Fixation

No phase Interventional Avulsion Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early Postoperative Rehabilitation Program, Conventional (Delayed) Rehabilitation Program.
Who it may be relevant to
Registry conditions: Avulsion Fracture. Basic parameters: 15 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • 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 flex
  • 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 st

Primary outcome measures

  • Change in Knee Range of Motion (ROM) [Time frame: Baseline (Postoperative Week 1), Week 6, and Week 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • University of Lahore Teaching Hospital, Lahore — Lahore

Identifiers

NCT: NCT07428291 · UOL/IREB/25/15/03/07

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗