N/A
Completed N=18
Bone Tunnel Widening Following ACL Reconstruction
Source: ClinicalTrials.gov NCT00198042 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Bone Tunnel Diameter — 14.4 mm
Summary
Hypothesis 1: There is less tunnel-widening with bone-patella tendon-bone graft compared with the hamstring graft when the same fixation method is used. Tunnel widening is greater with achilles tendon allografts versus autograft bone-patella tendon-bone and hamstring autografts.
Hypothesis 2: Tunnel widening occurs in the early post-operative period (< 8 weeks) when the tendon remodels within the bone tunnels.
Hypothesis 3: Low pre-operative bone mineral density is associated with tunnel widening.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Tunnel Diameter |
14.4 | — |
Eligibility Criteria
Inclusion Criteria
- Individuals within the age range of 18 to 55 years who are diagnosed with anterior cruciate insufficiency and have decided to undergo ACL reconstruction using autogenous graft will be included in the study.
Exclusion Criteria
- Individuals that have previous knee surgeries, multi-ligament injuries, systemic ligament disorders such as Ehlers Danlos syndrome or connective tissue disorders will be excluded from the study.
- Individuals who are pregnant or expect to be pregnant during the course of the study or who are especially concerned with X-ray exposure should also be excluded.
Data sourced from ClinicalTrials.gov (NCT00198042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.