Clinical trial NCT04951531: Allogeneic Bone-patellar Tendon-bone Transplantation
Official title: Allogeneic Bone-patellar Tendon-bone Transplantation to Reconstruct the Knee Joint Anterior Cruciate Ligament
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Anhui Medical University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
First posted: 2021-07-06
Enrollment: 84
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective To investigate the mid-term clinical effect of bone-patellar tendon-bone (BPTB) graft double-bundle reconstruction of the anterior cruciate ligament (ACL) of the knee joint under arthroscope.

Detailed description: The purpose of the present study was to report a unique technique of Double-bundle anterior cruciate ligament reconstruction (DB-ACLR) with a bone-patellar tendon- bone (BPTB) allograftand compare the clinical outcome of the new technique with that of the nonanatomic conventional transtibial Single-bundle anterior cruciate ligament reconstruction (SB-ACLR) with a BPTB allograft. The hypothesis was that the DB-ACLR with a BPTB allograft is technically feasible and may be superior in restoring anterior and rotational stability of the knee joint. Meanwhile, the back-pushing KT- 2000 arthrometer was used to confirm whether there were advantages of DB-ACLR in total anteroposterior stability.

Eligibility criteria: Inclusion Criteria:

From July 2005 to June 2008, 3757 ACLRs were performed in our department. A total of 111 patients chose to use allografts, and the other patients chose autologous semitendinosus and gracilis tendons (STGs). The patients selected DB or SB reconstruction based on their understanding about the information from the surgeons. Following the criteria of a prospective randomized study, 56 patients undergoing ACLRs with BPTB allografts were included in our study and were divided into a DB group and a SB group, each with 28 patients. 25 DB and 27 SB patients completed the final follow-up. Only patients between 16 and 50 years old who were undergoing primary operation were included, and younger patients had to have radiographic confirmation of a closed epiphysis.

Exclusion Criteria:

The exclusion criteria included age more than 50 years, narrow middle intercondylar width (\<12 mm measured during operation with the knee flexed to 90°), revision reconstruction, multiligament injury, bilateral ACLRs, total meniscectomy or more than one-third partial meniscectomy, and severe cartilage injury.

Primary outcomes:
measure: side-to-side difference
timeFrame: Before and 2 to 5 years after the operation
measure: total anteroposterior (AP) laxity
timeFrame: Before and 2 to 5 years after the operation
measure: pivot shift
timeFrame: Before and 2 to 5 years after the operation
measure: range of motion (ROM)
timeFrame: Before and 2 to 5 years after the operation
measure: isokinetic muscle strength evaluation
timeFrame: Before and 2 to 5 years after the operation
Secondary outcomes:
measure: International Knee Documentation Committee (IKDC) score
timeFrame: Before and 2 to 5 years after the operation
measure: Tegner score
timeFrame: Before and 2 to 5 years after the operation
measure: Lysholm score
timeFrame: Before and 2 to 5 years after the operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Sports Medicine, Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Jia-kuo Yu, Prof.
role: STUDY_CHAIR
References: