An observational study in Anterior Cruciate Ligament Rupture, sponsored by Isala. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-19.
Sponsored by Isala · Observational
Anterior Cruciate Ligament (ACL) reconstructions using hamstring grafts can be performed using one or two hamstring grafts, the semitendinosus (ST) tendon only, or both the semitendinosus and gracilis (ST/G) tendon. As most patients strive to return to sport nine months after reconstruction the purpose of this study was to compare the recovery of hamstring muscle strength during these first nine months after reconstruction using the ST or ST/G tendons.
Anterior cruciate ligament (ACL) reconstruction techniques are developing continuously. Studies have shown that anatomical positioning of the femur tunnel is an important predictor for the clinical outcome. This has led to the development of new reconstruction techniques with a more anatomical placement of the femur tunnel: the anteromedial portal (AMP) ACL reconstruction technique and, more recently, the tape locking screw (TLS) ACL reconstruction technique. Multiple retrospective studies have shown that patients have a better short term clinical outcome when the anteromedial portal (AMP) or the tape locking crew (TLS) reconstruction technique is used. At this moment, the most widely used technique is the AMP (performed in approximately 80% of the ACL reconstructions). The TLS technique is widely used in France and the available literature shows good short-term results.
A difference between the AMP and the TLS technique is that the AMP technique uses a double-bundle hamstring graft where the TLS technique uses a single-bundle hamstring graft. The idea is that using a single-bundle hamstring graft causes less hamstring muscle strength deficit. The available literature shows different outcomes of hamstring muscle strength deficit, although, there are no studies found in which the difference in hamstring muscle strength deficit between both techniques directly has been investigated.
Objective: The main objective of this study is to compare the hamstring muscle strength deficit after AMP and TLS reconstruction techniques.
The primary aim of this study is to investigate if there is a difference in hamstring muscle strength deficit at 60°/s flexion in patients with an ACL rupture (18-60 years) who received a tape locking screw ACL reconstruction versus patients who received an anteromedial portal ACL reconstruction 12 weeks after surgery.
The secondary aim of this study is to investigate if there is a difference in muscle strength deficit at 180°/s and 240°/s flexion and extension 12 weeks after surgery and 60°/s, 180°/s and 240°/s flexion and extension 20 weeks after surgery in patients who received a tape locking screw ACL reconstruction versus patients who received an anteromedial portal ACL reconstruction.
557 studies on the registry are indexed under Rupture; 97 are open to participants now.
This study's enrollment of 33 is below the median of 100 across 203 observational studies indexed under Rupture.
Browse Rupture studies →Isala is the lead sponsor of 36 studies on the registry; 10 are open to participants now.
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Patients will be recruited from the Orthopaedic outpatient clinic of the Isala in Zwolle if the patient has an ACL rupture and if there is an indication for surgical reconstruction with the AMP or TLS ACL reconstruction technique or at the (standard) 6 weeks follow-up appointment after AMP or TLS ACL reconstruction surgery
Exclusion Criteria:
Procedure: ACL hamstring reconstructions using semitendinosus (ST) tendon only
Procedure: ACL hamstring reconstructions using semitendinosus and gracilis (ST/G) tendon
ACL reconstruction with a ST tendon graft received a reconstruction according to the Tape Locking Screw technique (FH Industrie, Quimper, France) with a dedicated interference screw
ACL reconstruction with a ST/G tendon graft received a reconstruction with the anteromedial portal technique with endobutton fixation (Smith \& Nephew, London, UK).
Isokinetic muscle strength deficit
Comparing isokinetic muscle strength deficit (measured at 60°/s, 180°/s and 240°/s flexion with a the Biodex dynamometer) between both groups
Time frame: 38 weeks post-surgery
Change in isokinetic muscle strength deficit
Comparing the change in isokinetic muscle strength deficit (measured at 60°/s, 180°/s and 240°/s flexion with a the Biodex dynamometer) at 12, 20 and 38 weeks post-surgery
Time frame: 12, 20 and 38 weeks post-surgery
No study locations are listed for this record.
Plan to share: No — The datasets generated and/or analyzed during the current study are not publicly available due institutional privacy guideline but are available from the corresponding author on reasonable request
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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