University of Lahore Teaching Hospital, Lahore
Lahore, Punjab Province, 54000, Pakistan
Location status: Recruiting
Location contact
Abdul Jabbar, MSPTS
CONTACT
Abdul Jabbar, MSPTS
PRINCIPAL_INVESTIGATOR
Montiha Azeem, MSPTN
CONTACT
NCT Number: NCT07428291
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.
Interested in participating?
Request Info15 year–25 year
All sexes
Interventional
Not applicable
Lahore, Punjab Province, 54000, Pakistan
Location status: Recruiting
Abdul Jabbar, MSPTS
CONTACT
Abdul Jabbar, MSPTS
PRINCIPAL_INVESTIGATOR
Montiha Azeem, MSPTN
CONTACT
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
Contact information is provided by the study sponsor or research team.
Abdul Jabbar, MSPTS
CONTACT
Montiha Azeem, MSPTN
CONTACT
Abdul Jabbar
Other
Acronym: ER-TSAV
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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