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Comparison of soft tissue graft with intact bony attachment versus free graft (with no bony attachment) for treatment of knee ligament (anterior cruciate) injury

Comparison of ACL reconstruction with free quadrupled hamstring graft versus graft with preserved insertions: A Prospective, Randomized, Double blind Clinical Trial - ACLR

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/10/005090
Enrollment
50
Registered
2014-10-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: S835- Sprain of cruciate ligament of knee

Interventions

Intervention1: Free Hamstring graft after severing its insertion from the tibial attachement: 25 patients who will undergo ACL reconstruction by hamstrings tendon free autograft with the standard surg
however, the angle can be altered if the length o

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The proposed study will be a prospective study conducted on 50 patients assessed before surgery and followed-up after surgery for at least 1 year. Various exclusion criteria taken into account will be: • Group I: 25 patients who will undergo ACL reconstruction by hamstrings tendon free autograft. Group II: 25 patients who will undergo ACL reconstruction by a technique using hamstrings tendon autograft with preserved insertions A thorough clinical examination of both the knee joints will be done preoperatively that will include a detailed history, clinical examination and recording of the Cincinnati score21. X ray and MRI of the affected knee will be done in all the cases. Preoperative values of the various tests of proprioception will be recorded in both the affected and the normal knee. A Written and informed consent shall be taken from all the patients undergoing surgery. As it is a double blind trail, both the patient and the observer would not know about allocation of the patient in each group. 50 sealed envelops will be prepared containing the name of the surgical technique with 25 envelops belonging to each group. Allocation of the patient in each group will be made by picking up a sealed envelop by the patients after their consent. The requisite surgical technique will be performed as per the allocation envelop on all the patients by the same surgeon. After the surgery a code will be given to the patient, the details of which will not be disclosed to the assessor during the follow up visits. After the surgery, all the patients will undertake an intensive and same rehabilitating and exercise programme for at least 6 months. The patients will be regularly followed up and evaluated at 3 months, 6 months and 1 year post surgery, on the basis of the clinical tests, arthropometric test and evaluation with Cincinnati Knee Rating System.

Exclusion criteria

Exclusion criteria: Pregnancy • Multiple ligament injuries • Generalized ligament laxity • Previous surgery on the affected knee • Injury/ Surgery of the contra-lateral limb. • History of chronic disease such as Neurological / Metabolic disease i.e. polio/diabetes mellitus etc. • Stiff knee • Patients with any inflammatory disorders of the knee like osteoarthritis/ rheumatoid arthritis etc. • Patients with less than 3 weeks of duration after injury or with signs of inflammation whichever is later. • Younger patients with open epiphyses. These 50 patients will be randomly selected and divided into two groups depending upon the technique of ACL reconstruction.

Design outcomes

Primary

MeasureTime frame
1. To determine the mechanical differences in the reconstructed anterior cruciate ligament with free hamstring graft and the graft with preserved insertions. 2. To determine the proprioceptive differences in the reconstructed anterior cruciate ligament with free hamstring graft and the graft with preserved insertions. Timepoint: Follow up every month and final follow up at one year

Secondary

MeasureTime frame
To determine the long term clinical success of the reconstructed anterior cruciate ligament with free hamstring graft and the graft with preserved insertions. Timepoint: At the end of one year

Countries

India

Contacts

Public ContactRavi Gupta

Government Medical College and Hospital, Sector 32 Chandigarh

ravikgupta2000@yahoo.com9646121592

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026