Allogeneic Bone-patellar Tendon-bone Transplantation

Peking University

Status: Completed

Conditions: Anterior Cruciate Ligament Rupture

Treatments: Procedure: BPTB double-bundle allograft; Procedure: BPTB single-bundle autograft group; Procedure: BPTB single-bundle allograft group

Study type: Interventional

Funder types: Other

Identifiers

NCT04951531

200506A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 3 patient groups

BPTB double-bundle allograft group

Experimental group

Description:

The patient underwent arthroscopic double-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) allograft．

Treatment:

Procedure: BPTB double-bundle allograft

BPTB single-bundle allograft group

Active Comparator group

Description:

The patient underwent arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) allograft．

Treatment:

Procedure: BPTB single-bundle allograft group

BPTB single-bundle autograft group

Active Comparator group

Description:

The patient underwent arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) autograft．

Treatment:

Procedure: BPTB single-bundle autograft group