Allogeneic Bone-patellar Tendon-bone Transplantation
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 27, 2021
CompletedFirst Posted
Study publicly available on registry
July 6, 2021
CompletedJuly 6, 2021
June 1, 2021
6.3 years
June 27, 2021
June 27, 2021
Conditions
Outcome Measures
Primary Outcomes (5)
side-to-side difference
The side-to-side difference was measured at final follow-up by KT-2000 arthrometer (MEDmetric, San Diego, California) at 15 lb, 20 lb, and 30 lb in 30° and 90° of flexion.
Before and 2 to 5 years after the operation
total anteroposterior (AP) laxity
the total AP laxity (by back-pushing KT-2000 arthrometer measurement) of the knee joint were measured. The technique of the back-pushing KT-2000 arthrometer is as follows: at 30° or 90° of flexion, the patient relaxed himself or herself; next, the examiner pushed back the handle of the KT-2000 arthrometer with 20-lb force and set the zero point of the arthrometer while the tibia was kept in a back position. Then, the examiner applied an anterior force of 15 lb, 20 lb, and 30 lb, respectively, and recorded the results as the total AP laxity of the knee joint.
Before and 2 to 5 years after the operation
pivot shift
The pivot shift test of the knee joint is a test with an accuracy of 99% in the detection of knee anterior cruciate ligament injury.
Before and 2 to 5 years after the operation
range of motion (ROM)
Knee joint range of motion. Normal flexion 0 to 130°, extension 0°, flexion internal rotation 0 to 30°, flexion external rotation 0 to 40°.
Before and 2 to 5 years after the operation
isokinetic muscle strength evaluation
muscle strength was evaluated by Biodex dynamometer (Biodex, Shirley, New York) according to the manufacturer's guidelines. Strength testing was performed for knee flexion and knee extension at 60 and 120 deg/s. The mean peak torque of 5 maximal repetitions for each velocity was assessed to analyze the quadriceps and hamstring isokinetic strength, and the results of the operated leg were expressed as a percentage of that of the nonoperated side.
Before and 2 to 5 years after the operation
Secondary Outcomes (3)
International Knee Documentation Committee (IKDC) score
Before and 2 to 5 years after the operation
Tegner score
Before and 2 to 5 years after the operation
Lysholm score
Before and 2 to 5 years after the operation
Study Arms (3)
BPTB double-bundle allograft group
EXPERIMENTALThe patient underwent arthroscopic double-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) allograft．
BPTB single-bundle allograft group
ACTIVE COMPARATORThe patient underwent arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) allograft．
BPTB single-bundle autograft group
ACTIVE COMPARATORThe patient underwent arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) autograft．
Interventions
The patient underwent surgery of arthroscopic double-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) allograft．
The patient underwent surgery of arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) allograft．
The patient underwent surgery of arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) autograft．
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Sports Medicine, Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jia-kuo Yu, Prof.
Peking University Third Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2021
First Posted
July 6, 2021
Study Start
February 1, 2005
Primary Completion
June 1, 2011
Study Completion
June 1, 2012
Last Updated
July 6, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share