BPTB Versus Hamstring Autografts in ACL Reconstruction Among Professional Athletes (BPTB-HT ACL)
Bone-Patellar Tendon-Bone Versus Hamstring Tendon Autografts in ACL Reconstruction Among Professional Athletes: A Prospective Randomized Controlled Study With Mid-term Follow-up
This prospective randomized controlled study compares outcomes of ACL reconstruction using bone-patellar tendon-bone (BPTB) versus hamstring tendon (HT) autografts in professional athletes.
The primary outcome is isokinetic muscle strength assessment. Secondary outcomes include IKDC score, return to athletic activity, and complication rates. Patients are followed for five years.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This randomized controlled trial evaluates BPTB versus HT autografts in professional athletes undergoing ACL reconstruction. Patients with isolated ACL rupture were randomly assigned to either graft.
All procedures and rehabilitation protocols were standardized. The primary outcome was isokinetic assessment of quadriceps and hamstring strength using a dynamometer. Secondary outcomes included IKDC score, return to sport, and complications.
Patients were followed for five years to assess functional recovery and long-term outcomes.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypten
- Kasr Al-Ainy Hospital, Cairo University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Professional athletes actively engaged in competitive sports
- Age between 18 and 35 years
- Primary isolated anterior cruciate ligament (ACL) rupture confirmed clinically and by MRI
- Indicated for arthroscopic ACL reconstruction
- Willingness to participate and provide informed consent
Exclusion Criteria:
- Multiligamentous knee injuries
- Previous ACL reconstruction on the affected knee
- Lower limb malalignment
- Advanced chondral lesions requiring additional surgical procedures
- Associated fractures around the knee
- Inability to comply with follow-up protocol
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: BPTB Group
Participants undergoing ACL reconstruction using bone-patellar tendon-bone (BPTB) autograft.
|
Arthroscopic anterior cruciate ligament reconstruction using bone-patellar tendon-bone autograft with interference screw fixation.
|
|
Aktiv komparator: Hamstring Group
Participants undergoing ACL reconstruction using hamstring tendon autograft (semitendinosus and gracilis).
|
Arthroscopic anterior cruciate ligament reconstruction using semitendinosus and gracilis tendon autograft with appropriate fixation technique.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Isokinetic Quadriceps and Hamstring Muscle Strength
Tidsram: 12 months postoperatively
|
Isokinetic dynamometric assessment of quadriceps and hamstring muscle strength expressed as peak torque percentage relative to the contralateral limb using a standardized testing protocol.
|
12 months postoperatively
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
International Knee Documentation Committee (IKDC) Score
Tidsram: 12 months postoperatively
|
Patient-reported functional outcome measured using the IKDC subjective knee evaluation form.
|
12 months postoperatively
|
|
Time to Return to Athletic Activity
Tidsram: Up to 12 months postoperatively
|
Time required for patients to return to pre-injury level of athletic activity.
|
Up to 12 months postoperatively
|
|
Postoperative Complications
Tidsram: Up to 60 months postoperatively
|
Incidence of complications including infection, anterior knee pain, extension lag, stiffness, and graft re-rupture.
|
Up to 60 months postoperatively
|
|
Knee function using KOOS score
Tidsram: 60 months postoperatively
|
Patient-reported outcomes assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), including subscales:
Scores reported on a 0-100 scale (higher scores indicate better function). |
60 months postoperatively
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- N-360-2017
Plan för individuella deltagardata (IPD)
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