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

Completed

• Conditions: Sprain of cruciate ligament of knee,

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

Brief Summary

Anterior cruciate ligament injury is a common injury seen in young adults resulting in ACL deficient knee. The natural course of an untreated ACL deficient knee results in progressive deterioration of the function of the knee joint and progressive meniscal and chondral damage ultimately leading to degenerative disease of the knee joint. The most accepted treatment of an ACL deficient knee is reconstruction of anterior cruciate ligament arthroscopically by using either a free bone patellar tendon bone graft (BPTB) or a free quadrupled hamstring graft (semitendinosus and gracilis). The use of free grafts requires fixation of both the ends of the graft in femoral and tibial tunnels by using mechanical fixation devices like screws, staples, endobuttons etc.

There have  been concerns regarding the use of free grafts in terms of loss of the proprioceptive sensations provided by the normal anterior cruciate ligament.

We have been using a new surgical technique in our institution where the quadrupled hamstring graft is being used without severing the insertions of the hamstring tendons. Since the insertions of the hamstring tendons at the tibial end are nor severed, the new technique does not require a fixation device to be used on the tibial end of the graft thus resulting in the reduced cost of the surgery.  In addition, we hypothesize that preserving the insertions of the hamstring tendons may be beneficial to the patient in terms of providing a better proprioceptive sensation to the knee joint due to the function of neural receptors contained in the ends of the tendons/ aproneurosis.

The preliminary results of the technique had been encouraging and have already been published.

The present study is proposed to know the mechanical and proprioceptive differences  between the traditional technique of using free graft and the new technique of the graft with preserved insertions.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-30
• Study Completion: 2014-04-30
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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

• 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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To determine the long term clinical success of the reconstructed anterior cruciate ligament with free hamstring graft and the graft with preserved insertions.

Trial Locations

Locations (1)

Department of Orthopaedics, Block D, Level III; 🇮🇳 Chandigarh, CHANDIGARH, India

Department of Orthopaedics, Block D, Level III

🇮🇳Chandigarh, CHANDIGARH, India

Ravi Gupta

Principal investigator

9646121592

ravikgupta2000@yahoo.com