Anterior Cruciate Ligament RuptureNCT05924178
Effects of Preoperative Rehabilitation on Tendon Healing, Bone Mineral Density, and Cartilage After ACLR and Patellar Dislocation
A study testing exercise rehablitation and routine treatment in people with Anterior Cruciate Ligament Rupture, run by Peking University Third Hospital at 1 site in China.
Trial summary
To explore the effect of preoperative exercise rehabilitation on bone mineral density, tendon bone healing, change of cartilage, and gait feature in patients with anterior cruciate ligament rupture. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- exercise rehablitation and routine treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2023to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18~40 years old, diagnosed ACL rupture or Patellar Dislocation by MRI;
- The first unilateral ligamenta reconstruction at our hospital;
Who cannot join
- Be older than 40 years, or less than 18 years old
- Severe injury to other knee ligaments
- History of knee trauma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
ren shuang, xixishuang123@126.com
About this study
Official title: A Study on the Effect of Exercise Rehabilitation on Bone Mineral Density, Reconstruction Ligament Tendon Bone Healing and Cartilage After ACL Rupture and Patellar Dislocation
To explore the effect of preoperative exercise rehabilitation on bone mineral density, tendon bone healing, change of cartilage, and gait feature in patients with anterior cruciate ligament rupture.
Read the detailed description
Anterior Cruciate Ligament (ACL) injury is one of the most common sports injuries. It is a serious knee injury. The fracture of ACL can cause functional instability of knee joint, damage of meniscus and articular cartilage, and even induce knee osteoarthritis and other diseases. It has great influence on knee joint and even lower limb function of patients. Arthroscopic ACL reconstruction has become the first choice in clinical treatment of ACL fracture.
ACL fracture can cause local knee joint osteoporosis, and reconstruction surgery can also affect tendon bone healing, bone canal enlargement, rehabilitation period, gait, articular cartilage degradation, etc.
This study intends to conduct preoperative rehabilitation intervention for young people with anterior fork rupture, and explore the effects of exercise rehabilitation on knee bone mineral density, muscle strength, proprioceptive ability and other aspects after ACL rupture, as well as the effects of knee bone mineral density, tendon bone healing, bone tunnel aperture, motor function, gait characteristics and cartilage degradation after reconstruction.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- exercise rehablitation, routine treatment
- 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.
exercise rehablitationBehavioural
Preoperative exercise rehabilitation in experimental group was performed.
routine treatmentBehavioural
The control group receives conventional treatment preoperative.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Before ACL reconstruction,40 minutes of rehabilitation training was performed 3 times a week for 6 weeks, and gotted regular treatment. The ACL reconstruction was followed by a 0.5 year rehabilitation. Receives: Behavioral: exercise rehablitation |
| control group | Active comparator | Regular rehabilitation training was not performed before ACL reconstruction, got regular treatment. The ACL reconstruction was followed by a 0.5 year rehabilitation. Receives: Behavioral: routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of tendon bone healing
tendon bone healing by knee MRI
Measured: At 6 monthes post operation.
Grade of tendon bone healing
tendon bone healing by knee MRI
Measured: At 1 year post operation.
balanced capacity
Y balance test
Measured: At preoperative.
balanced capacity
Y balance test
Measured: At 6 monthes post operation.
balanced capacity
Y balance test
Measured: At 1 year post operation.
knee T1 rho value
knee T1 rho value by functional MRI
Measured: At 6 months post operation.
knee T1 rho value
knee T1 rho value by functional MRI
Measured: At 1 year post operation.
knee T2 value
knee T2 rho value by functional MRI
Measured: At 6 months post operation.
knee T2 value
knee T2 rho value by functional MRI
Measured: At 1 year post operation.
knee extension angles
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Measured: At 6 months post operation.
knee extension angles
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Measured: At 1 year post operation.
Graft maturity
tendon bone healing by knee MRI
Measured: At 6 monthes post operation.
Graft maturity
tendon bone healing by knee MRI
Measured: At 1 year post operation.
bone mineral density
bone mineral density by knee DEX
Measured: At preoperative.
bone mineral density
bone mineral density by knee DEX
Measured: At 6 monthes post operation.
bone mineral density
bone mineral density by knee DEX
Measured: At 1 year post operation.
isokinetic muscle strength
Knee isokinetic strength test
Measured: At preoperative.
isokinetic muscle strength
Knee isokinetic strength test
Measured: At 6 monthes post operation.
isokinetic muscle strength
Knee isokinetic strength test
Measured: At 1 year post operation.
Grade of tendon bone healing
tendon bone healing by knee MRI
Measured: At 2 years post operation.
balanced capacity
Y balance test
Measured: At 2 years post operation.
Graft maturity
tendon bone healing by knee MRI
Measured: At 2 years post operation.
isokinetic muscle strength
Knee isokinetic strength test
Measured: At 2 years post operation.
Secondary outcomes (7)
The HU value of CT
CT test
Measured: at pre-operation
Thigh Circumference
the circumference of 15 cm above the superior aspect of the patella
Measured: At 2 years post operation.
Thigh Circumference
the circumference of 15 cm above the superior aspect of the patella
Measured: At 1 year post operation.
Thigh Circumference
the circumference of 15 cm above the superior aspect of the patella
Measured: At 6 monthes post operation.
Thigh Circumference
the circumference of 15 cm above the superior aspect of the patella
Measured: At pre-operation.
Single-Leg Hop
a maximal-distance hop
Measured: At 1 year post operation.
Single-Leg Hop
a maximal-distance hop
Measured: At 2 years post operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start10 Jul 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924178
- Sponsor's protocol ID
- M2022837
- Status last verified
- Apr 2026
- First submitted
- 28 May 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Can contact the author to communicate and obtain the corresponding data.
Publications
Wu Y, Yan W, Dai W, Ren S, Ao Y, Gong X. The effect of preoperative rehabilitation exercises on postoperative bone mineral density, tendon-bone healing, and physical function after anterior cruciate ligament reconstruction: a multi-center randomized controlled clinical trial. BMC Sports Sci Med Rehabil. 2026 Jun 30. doi: 10.1186/s13102-026-01841-3. Online ahead of print.
PubMed 42374474
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effect of Exercise Rehabilitation on Bone Mineral Density, Reconstruction Ligament Tendon Bone Healing and Cartilage After ACL Rupture and Patellar Dislocation
- ClinicalTrials.gov ID
- NCT05924178
- Acronym / sponsor ID
- M2022837
- Conditions
- Anterior Cruciate Ligament Rupture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the effect of preoperative exercise rehabilitation on bone mineral density, tendon bone healing, change of cartilage, and gait feature in patients with anterior cruciate ligament rupture.
Detailed description
Anterior Cruciate Ligament (ACL) injury is one of the most common sports injuries. It is a serious knee injury. The fracture of ACL can cause functional instability of knee joint, damage of meniscus and articular cartilage, and even induce knee osteoarthritis and other diseases. It has great influence on knee joint and even lower limb function of patients. Arthroscopic ACL reconstruction has become the first choice in clinical treatment of ACL fracture.
ACL fracture can cause local knee joint osteoporosis, and reconstruction surgery can also affect tendon bone healing, bone canal enlargement, rehabilitation period, gait, articular cartilage degradation, etc.
This study intends to conduct preoperative rehabilitation intervention for young people with anterior fork rupture, and explore the effects of exercise rehabilitation on knee bone mineral density, muscle strength, proprioceptive ability and other aspects after ACL rupture, as well as the effects of knee bone mineral density, tendon bone healing, bone tunnel aperture, motor function, gait characteristics and cartilage degradation after reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: exercise rehablitationBefore ACL reconstruction,40 minutes of rehabilitation training was performed 3 times a week for 6 weeks, and gotted regular treatment. The ACL reconstruction was followed by a 0.5 year rehabilitation. |
| control group | Active comparator | Behavioral: routine treatmentRegular rehabilitation training was not performed before ACL reconstruction, got regular treatment. The ACL reconstruction was followed by a 0.5 year rehabilitation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18~40 years old, diagnosed ACL rupture or Patellar Dislocation by MRI;
- The first unilateral ligamenta reconstruction at our hospital;
Key exclusion criteria (3 listed)
- Be older than 40 years, or less than 18 years old
- Severe injury to other knee ligaments
- History of knee trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise rehablitationPreoperative exercise rehabilitation in experimental group was performed. | Behavioural | experimental group |
| routine treatmentThe control group receives conventional treatment preoperative. | Behavioural | control group |
Primary outcome
Grade of tendon bone healing
Time frame: At 6 monthes post operation.
tendon bone healing by knee MRI
Grade of tendon bone healing
Time frame: At 1 year post operation.
tendon bone healing by knee MRI
balanced capacity
Time frame: At preoperative.
Y balance test
balanced capacity
Time frame: At 6 monthes post operation.
Y balance test
balanced capacity
Time frame: At 1 year post operation.
Y balance test
knee T1 rho value
Time frame: At 6 months post operation.
knee T1 rho value by functional MRI
knee T1 rho value
Time frame: At 1 year post operation.
knee T1 rho value by functional MRI
knee T2 value
Time frame: At 6 months post operation.
knee T2 rho value by functional MRI
knee T2 value
Time frame: At 1 year post operation.
knee T2 rho value by functional MRI
knee extension angles
Time frame: At 6 months post operation.
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
knee extension angles
Time frame: At 1 year post operation.
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
Graft maturity
Time frame: At 6 monthes post operation.
tendon bone healing by knee MRI
Graft maturity
Time frame: At 1 year post operation.
tendon bone healing by knee MRI
bone mineral density
Time frame: At preoperative.
bone mineral density by knee DEX
bone mineral density
Time frame: At 6 monthes post operation.
bone mineral density by knee DEX
bone mineral density
Time frame: At 1 year post operation.
bone mineral density by knee DEX
isokinetic muscle strength
Time frame: At preoperative.
Knee isokinetic strength test
isokinetic muscle strength
Time frame: At 6 monthes post operation.
Knee isokinetic strength test
isokinetic muscle strength
Time frame: At 1 year post operation.
Knee isokinetic strength test
Grade of tendon bone healing
Time frame: At 2 years post operation.
tendon bone healing by knee MRI
balanced capacity
Time frame: At 2 years post operation.
Y balance test
Graft maturity
Time frame: At 2 years post operation.
tendon bone healing by knee MRI
isokinetic muscle strength
Time frame: At 2 years post operation.
Knee isokinetic strength test
7 secondary outcomes
The HU value of CT
Time frame: at pre-operation
Thigh Circumference
Time frame: At 2 years post operation.
Thigh Circumference
Time frame: At 1 year post operation.
Thigh Circumference
Time frame: At 6 monthes post operation.
Thigh Circumference
Time frame: At pre-operation.
Single-Leg Hop
Time frame: At 1 year post operation.
Single-Leg Hop
Time frame: At 2 years post operation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Derived from this study: PubMed 42374474Wu Y, Yan W, Dai W, Ren S, Ao Y, Gong X. The effect of preoperative rehabilitation exercises on postoperative bone mineral density, tendon-bone healing, and physical function after anterior cruciate ligament reconstruction: a multi-center randomized controlled clinical trial. BMC Sports Sci Med Rehabil. 2026 Jun 30. doi: 10.1186/s13102-026-01841-3. Online ahead of print.
- Individual participant dataSharing planned: Yes. Can contact the author to communicate and obtain the corresponding data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise rehablitation and routine treatment 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 15 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuang Ren (17610252992, xixishuang123@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade of tendon bone healing (time frame: At 6 monthes post operation.). The study lists 23 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 NCT05924178, which also lists 1 linked publication.
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 15 Apr 2026.