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Anterior Cruciate Ligament RuptureNCT04951531

Allogeneic Bone-patellar Tendon-bone Transplantation

A study testing BPTB double-bundle allograft, BPTB single-bundle allograft group and BPTB single-bundle autograft group in people with Anterior Cruciate Ligament Rupture, run by Peking University Third Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 50 years
Conditions the study is for
Anterior Cruciate Ligament Rupture
What is being tested?
BPTB double-bundle allograft, BPTB single-bundle allograft group and BPTB single-bundle autograft group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteChina
Study dates
1 Feb 2005to 1 Jun 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

China1 site

  • Institute of Sports Medicine, Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

Other trials in China

About this study

Official title: Allogeneic Bone-patellar Tendon-bone Transplantation to Reconstruct the Knee Joint Anterior Cruciate Ligament

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.

Read the 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.

Being tested
BPTB double-bundle allograft, BPTB single-bundle allograft group, BPTB single-bundle autograft group
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BPTB double-bundle allograftProcedure or surgery

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

  • BPTB single-bundle allograft groupProcedure or surgery

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

  • BPTB single-bundle autograft groupProcedure or surgery

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

Study groups in NCT04951531
Study groupRoleWhat they receive
BPTB double-bundle allograft groupExperimentalThe patient underwent arthroscopic double-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) allograft．
Receives: Procedure: BPTB double-bundle allograft
BPTB single-bundle allograft groupActive comparatorThe patient underwent arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) allograft．
Receives: Procedure: BPTB single-bundle allograft group
BPTB single-bundle autograft groupActive comparatorThe patient underwent arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) autograft．
Receives: Procedure: BPTB single-bundle autograft group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Before and 2 to 5 years after the operation

  2. 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.

    Measured: Before and 2 to 5 years after the operation

  3. 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.

    Measured: Before and 2 to 5 years after the operation

  4. 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°.

    Measured: Before and 2 to 5 years after the operation

  5. 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.

    Measured: Before and 2 to 5 years after the operation

Secondary outcomes (3)

  1. International Knee Documentation Committee (IKDC) score

    At present, it is recognized internationally that IKDC has relatively high reliability, effectiveness and sensitivity for the assessment of ligament injuries, especially anterior cruciate ligament injuries.

    Measured: Before and 2 to 5 years after the operation

  2. Tegner score

    This score is widely used by exercise assessors for patients with knee joint disease. This scoring method divides the patient's exercise level into 0-10 points, 0 as disability, and 10 as being able to participate in national competitive sports.

    Measured: Before and 2 to 5 years after the operation

  3. Lysholm score

    This score is often used together with the Tegner score. The scores of this scoring system are generally high and focus more on the assessment of daily activities rather than sports.

    Measured: Before and 2 to 5 years after the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2021
  2. Study start1 Feb 2005
  3. Primary completion1 Jun 2011
  4. Study completion1 Jun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04951531
Sponsor's protocol ID
200506A
Status last verified
Jun 2021
First submitted
27 Jun 2021
Last updated
6 Jul 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing BPTB double-bundle allograft, BPTB single-bundle allograft group and BPTB single-bundle autograft group in people with Anterior Cruciate Ligament Rupture, run by Peking University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

side-to-side difference (time frame: Before and 2 to 5 years after the operation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04951531.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.

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