Influence of Combined Double-Bundle ACL Reconstruction With Lateral Retinacular Release to Prevent Patellofemoral Malalignment in Isolated ACL Rupture
Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT06004297
Collaborator
(none)
100
1
3
11.4
8.8
Study Details
Study Description
Brief Summary
Anterior knee pain which might be due to patellofemoral malalignment is an inevitable post operative complication after an ACL reconstruction (ACLR). We combined the double bundle ACLR technique with lateral release technique to prevent patellofemoral malalignment post ACLR.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Influence of Combined Double-Bundle ACL Reconstruction With Lateral Retinacular Release to Prevent Patellofemoral Malalignment in Isolated ACL Rupture: a Randomized Controlled Trial
Actual Study Start Date
:
Jan 7, 2019
Actual Primary Completion Date
:
Dec 20, 2019
Actual Study Completion Date
:
Dec 20, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group 1 Single bundle group |
Procedure: ACL reconstruction
performed arthroscopically
|
| Active Comparator: Group 2 Double bundle only group |
Procedure: ACL reconstruction
performed arthroscopically
|
| Experimental: Group 3 Double bundle with lateral release group |
Procedure: ACL reconstruction
performed arthroscopically
|
Outcome Measures
Primary Outcome Measures
- TTTG value [6 months]
tibial tuberosity to trochlea groove, radiographic outcome
Secondary Outcome Measures
- Kujala score [6 months]
functional outcome
Eligibility Criteria
Criteria
Ages Eligible for Study:
16 Years
to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
unilateral isolated total ACL rupture
-
normal BMI
Exclusion Criteria:
- flexion contracture more than 200, presence of anterior knee pain before surgery, Q angle >140 in males and >170 in females, presence of a patellar tilting, rupture of other ligaments, and muscular dysfunction.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty of Medicine Universitas Indonesia | Jakarta | Indonesia |
Sponsors and Collaborators
- Indonesia University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ludwig Andre Pontoh,
DR., dr., Sp.OT(K),
Indonesia University
ClinicalTrials.gov Identifier:
NCT06004297
Other Study ID Numbers:
- AP/2019/003
First Posted:
Aug 22, 2023
Last Update Posted:
Aug 22, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: