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

Not Applicable

Completed

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

• Registration Number: CTRI/2014/10/005090
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-04-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

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:

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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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified