An evaluation of knee stability and functions following ACL reconstruction (semitendinosus/gracillis grafts) comparing manually versus mechanically tensioned grafts (using a tensioning device).

An evaluation of knee stability and functions following Anterior Cruciate Ligament (ACL) reconstruction (semitendinosus/gracillis grafts) comparing manually versus mechanically tensioned grafts (using a tensioning device).

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000389505

Enrollment

Registered

2006-09-05

Start date

2006-07-14

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We hypothesise that participants receiving a mechanically tensioned ACL graft have superior knee stability and hence function.

Interventions

Two tensioning methods for ACL reconstruction will be used: 1.Manual Tensioning (control group-semitendinosus/gracillis grafts) 2.Tensioning with a Graft Tensioner (intervention group-a tensioning device). Both groups will follow the same postoperative protocols. Estimated time for procedure 70 mins Surgical protocol Tensioning Device Intervention Group: The graft is fixed to the tensioning device via suture tying The grafts are tensioned to 60 N for Semitendinosis and 40 Nfor gracillis The knee is cycled 15 times through full range of motion The tension is checked and adjusted so that 50 N remain on the semitendinosis graft and 30 N on the gracillis graft The tibial screw is then fixed in situ with the tension maintained The femoral fixation will be standardised Post Operative Management Both groups will be reconstructed using the semitendinosus/gracilis graft. The same postoperative protocols will be adhered to which involves an accelerated rehabilitation approach. The aim of this protocol is normal gait no aids by 2 weeks, normal range of movement, and minimal swelling within 6 weeks, and the aim of returning to sport in 6-9 months. Patients will be assessed preoperatively, and at 2 weeks, 3, 6 and 12 months post operatively using the measures outlined above.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Adult participants.The expected age range of subjects undergoing ACL surgery is between 18-40 years.Patients undergoing primary ACL reconstructionDiagnosis of ACL ruptureHealthy and no comorbidities that would prevent participating in the required rehabilitation programmeNormal mentation with the ability to accurately follow commandsAbility to participate voluntarily and provide signed informed consent.

Exclusion criteria

Persons with concomitant medical conditions such as malignant tumours or severe Chronic Obstructive Pulmonary Disease that would prevent participation in their rehabilitation programmeInability to follow commandsPersons not able to mobilise in a bipedal manner with or without a walking aid.Conditions preventing full weight bearing post-operativelyThe inability to provide signed informed consentRevision ACL or any previous major arthrotomy on the knee to be operated onPersons not suitable for a gracilis/semitendinosus graftConcomitant meniscal or collateral ligament injuries or any lower limb injury affecting the knee.

Outcome results