Rajiv Gandhi University of Health Sciences



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|RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, |

|BANGALORE, KARNATAKA. |

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|ANNEXURE II |

|PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION |

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|1. |Name of the candidate and address (in block letters)|DR. RAVIRAJ TANTRY |

| | |POST GRADUATE STUDENT, |

| | |DEPARTMENT OF ORTHOPAEDICS, |

| | |S.D.M COLLEGE OF MEDICAL SCIENCES & HOSPITAL, |

| | |MANJUSHREE NAGAR, SATTUR, |

| | |DHARWAD – 580009. |

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|2. |Name of the Institution | |

| | |SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF MEDICAL SCIENCES AND HOSPITAL, |

| | |MANJUSHREE NAGAR, SATTUR, |

| | |DHARWAD- 580009. |

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|3. |Course of study and subject |M.S (ORTHOPAEDICS) |

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|4. |Date of admission to the course |31-05-2011 |

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|5. |Title of the Topic |EVALUATION OF OUTCOME OF MEDIAL OPENING WEDGE HIGH TIBIAL OSTEOTOMY WITH AN |

| | |ORTHOFIX EXTERNAL FIXATOR FOR UNICOMPARTMENTAL OSTEOARTHRITIS OF KNEE. |

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|6. |BRIEF RESUME OF THE INTENDED WORK: |

| |6.1 Need for the study: |

| |Knee osteoarthritis ranks among the most common disability in adults and the prevalence is projected to increase sharply over next two |

| |decades.1 Medial compartment osteoarthritis of the knee leading to varus deformity and subsequent disability is a common problem. |

| |During early stages of osteoarthritis, non surgical treatment options include weight loss, low impact activity and physiotherapy. As the |

| |disease progress to end stage osteoarthritis, the surgical treatment options are high tibial osteotomy, unicompartmental arthroplasty and |

| |total knee arthroplasty. Arthroplasty is considered a good option for healthier patient, older than 60 years with good long terms outcome |

| |reported. However concern remains regarding the longevity of the implants in younger patients.2 |

| |High tibial osteotomy is an accepted surgical technique for treatment of medial compartment arthrosis of knee in younger patients. Selection |

| |of the appropriate patients, extensive pre operative planning and accurate surgical technique are essential for successful outcome. The |

| |methods of high tibial osteotomy include open wedge osteotomy and closed wedge osteotomy, the latter procedure being more popular. This |

| |procedure stands ahead of closed wedge osteotomy because the Peroneal nerve is not in jeopardy and there is no disruption of proximal |

| |tibiofibular joint and lateral collateral ligaments woth achievement of more precise correction.3 |

| |The biomechanical principle of high tibial osteotomy is to redistribute the weight bearing forces from the worn medial compartment across to |

| |the lateral compartment thereby relieves pain and slows the disease progression. |

| |Most studies have used Circular External fixator for correction of varus deformity, which are complex and cause patient discomfort. However |

| |the Unilateral external fixator tends to better accepted by the patient and is easy to use by the surgeons and is found to be safe and simple|

| |corrective procedure for varus deformity of proximal tibia with few complications.4 |

| |The aim of my study is to evaluate the outcome of medial opening wedge high tibial osteotomy with an orthofix external fixator for |

| |unicompartmental osteoarthritis patients attending SDM college of medical sciences and hospital, Dharwad. |

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| |6.2 Review of the literature |

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| |Catherine hui et al in their study concluded that high tibial osteotomy can be effective for periods longer than 15 years, however results do|

| |deteriorate with time.2 |

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| |Chang wug oh et al in their study on 13 patients concluded that hemicallotasis using a unilateral external fixator is a safe and simple |

| |corrective procedure for varus deformity of the proximal tibia with a few complications.4 |

| |Roberto Rossi et al in their study concluded that high tibial osteotomy is a widely performed procedure and good results can be achieved with|

| |appropriate patient selection and precise surgical technique and also found that in young active patients, correction of alignment is |

| |essential in relieving symptoms and achieving durable results.5 |

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| |Pietro maniscalco in his study concluded that the external fixator has a number of advantages over the utilization of plates and screws |

| |or the Insall procedure. The stability of external fixator allows early walking, limiting the discomfort of the initial prohibition of |

| |weight bearing that must be prescribed in case of plates or the immobilization in plaster necessary with the Insall procedure.6 |

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| |M.pfahler et al in their study on 104 high tibial lateral osteotomies noted that 90% of the patients included in the study stated that |

| |the results met their expectations and given the same circumstances, they would have operation once again and the remaining 10% had poor |

| |result. He concluded that high tibial valgus osteotomy provides good pain relief and improved function in carefully selected patients.7 |

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| |Mark.B.Coventry in his study concluded that 67% of knees were less painful at a mean of 9 years of operation, 24% of people had same amount |

| |of pain and 8% had severe pain.8 |

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| |R.D. Gaasbeek in his study concluded that there was significant loss of correction in closed wedge osteotomy group and a significantly more |

| |stable fixation with hemicallotasis technique and the hospital stay with hemicallotasis was significantly shorter.9 |

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| |Annuziato amendola in his study concluded that high tibial osteotomy is a reliable procedure for medial arthrosis of knee with proper patient|

| |selection and a precise surgical technique and the outcome gradually deteriorates with time.10 |

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| |A study done by G F McCoy, H K Graham, C J McClelland concluded that the main definite indications for tibial osteotomy are relatively |

| |young patients, with painful, mobile knees, and valgus or varus deformity in the range 200 valgus to 150 varus (weight-bearing) with |

| |relative sparing of one compartment.11 |

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| |Goran Magyar et all in their study concluded that opening wedge osteotomy has an advantage of being relatively safe to perform and it is easy|

| |to achieve planned correction and also said that hemicallotasis seems to be a valid alternative to conventional osteotomy.12 |

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| |Federico Dettoni in his study concluded that with correct indications , both treatment produce durable and predictable outcomes in the |

| |treatment of medial compartment arthrosis of the knee and there is no evidence of superior results of one treatment over the other.13 |

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| |In a study done by Himanshu kataria and sardar singh, they concluded that 11 of the 20 are graded as good, 6 were fair and 3 were poor at |

| |average 20 months follow up. Using his symptom scoring system 30% patients were good , 55% were fair and 15% were poor after the |

| |operation.14 |

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| |Varun Chandra and sanjay panday in their study on high tibial osteotomy concluded in a operated group (n=43) that 23 patients had no pain in|

| |their daily life activities,18 had pain occasionally and 3 patients felt pain on walking up and down the stairs.15 |

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| |6.3 Aims and Objectives of the study: |

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| |1) To Evaluate the outcome of medial opening wedge high tibial osteotomy with an orthofix external fixator for unicompartmental |

| |osteoarthritis. |

| |2) To evaluate the deformity correction by X-ray, CT Scanogram. |

| |3) To assess the relief of symptoms of osteoarthritis, function, pain and patient satisfaction using Knee society scoring system. |

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|7. |Materials and Methods: |

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| |7.1 Source of data: |

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| |Study subjects: |

| |All the patients admitted in the orthopaedic ward of SDM College of Medical Sciences and Hospital, Dharwad, with the complaints of knee pain |

| |and on clinical examination suspected of medial unicompartmental osteoarthritis. |

| |. |

| |Inclusion criteria: |

| |All the physiologically young patients admitted in the orthopaedics ward with the complaints of knee pain and on clinical examination have |

| |full range of motion at the knee and require surgical intervention under study and willing for surgery. |

| |. |

| |Exclusion criteria: |

| |The patients with bicompartmental and tricompartmental osteoarthritis. |

| |Restricted range of movements at knee i.e. knee flexion of less than 90 degrees or flexion contracture of more than 15 degrees |

| |Patients aged above 65 years |

| |Deformity correction of more than 20 degree . |

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| |Study Area: |

| |Department of orthopaedics, S.D.M College of Medical Science and Hospital, Sattur, Dharwad, Karnataka |

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| |Study Period: |

| |The study will be carried out over a period of 1 year from December 2011 to November 2012. |

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| |7.2 Methods of collection of data: |

| |Study Design: |

| |A Retrospective and Prospective study. |

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| |Sample Size: |

| |All patients who are fitting into my inclusion criteria will be taken under study. |

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| |Study Methods: |

| |All the patients attending the orthopedics outpatient department with the complaints of knee pain and on clinical examination have |

| |unicompartmental medial osteoarthritis. |

| |Clinical examination to be done by an orthopaedic surgeon and medial opening wedge high tibial osteotomy with an orthofix external fixator |

| |done by the other orthopedic surgeon. |

| |Baseline and follow up survey consists of X-ray, CT scanogram of knee collected from Radio diagnosis department. |

| |Parameters used: |

| |Name, Age, Sex, Occupation of the patient |

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| |Clinical examination- 1-Medial joint line tenderness |

| |2-Adequate range of movement at knee |

| |3-Measurement of Angular deformity |

| |4-Anterior Drawer test. |

| |5-Posterior Drawer test |

| |6-Mcmurray’s test |

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| |c) Routine Blood investigations-1) Complete blood count |

| |2) Blood urea, Serum creatinine, |

| |3) Random Blood Sugar |

| |4) HIV, HBsAG |

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| |d) Radiographic findings - 1-Knee-anteroposterior view with full weight bearing. |

| |2-Knee-lateral view with full weight bearing |

| |3-CT Scanogram- to measure the mechanical axis of the |

| |limb |

| |e) Diagnostic arthroscopy - To assess the lateral compartment of knee and meniscus |

| |pathology. |

| |Data Collection: |

| |Patient proforma will be collected as in the annexure I. |

| |Written informed consent will be collected as in the annexure III. |

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| |Statistical Analysis: |

| |Percentages and proportions will be applied to assess the clinical outcome of the surgery under study. |

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| |7.3 Does the study require any investigations or interventions to be conducted on patients or other Humans or animals? If so, please |

| |describe briefly. |

| |YES, |

| |The study requires clinical examination of the patient, routine blood investigations , X-ray, |

| |CT scanogram and Diagnostic arthroscopy of the knee and Medial opening wedge high tibial osteotomy with an orthofix external fixator for |

| |knee. |

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| |7.4 Has ethical clearance been obtained from ethical committee of your institution in case of 7.3? |

| |YES. |

| |The Ethical Clearance has been obtained from the Institutional Ethical committee of SDM College of Medical Sciences and Hospital, |

| |Dharwad. (Annexure III) |

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| |List of References: |

|8. | |

| |Trevor B. Birmingham, J. Robert giffin, Bert M. Chesworth, Dianne M. Bryant, Robert B. Litchfield, Kevin Willits, Thomas R. Jenkyn, Peter J. |

| |Fowler. Medial Opening Wedge High Tibial Osteotomy: A Prospective Cohort Study of Gait, Radiographic and Patient-Reported Outcome. Arthritis |

| |& Rheumatism (Arthritis Care & Research) 2009;61(5):648-57. |

| |Catherine Hui, Lucy J Salmon, Alison Kok, Heidi A. Williams, Niels Hockers, Willem M. van der Tempel, Rishi Chana, Leo A. Pinczewski. |

| |Long-Term Survival of High Tibial Osteotomy for Medial Compartment Osteoarthritis of the Knee. The American Journal of Sports Medicine |

| |2011;39(1):64-70 |

| |Su Chan Lee, Kwang Am Jung, Chang Hyun Nam, Soong Hyun Jung, Seung Hyun Hwang. The Short-term Follow-up Results of Open Wedge High Tibial |

| |Osteotomy with Using an Aescula Open Wedge Plate and an Allogenic Bone Graft: The Minimum 1-Year Follow-up Results. Clinics in Orthopedic |

| |Surgery 2010;2:47-54. |

| |Chang-Wug Oh, Sung-Jung Kim, Sung-Ki Park, Hee-June Kim, Hee-Soo Kyung, Hwan-Sung Cho, Byung-Chul Park, Joo-Chul Ihn. Hemicallotasis for |

| |correction of varus deformity of the proximal tibia using a unilateral external fixator. J Orthop Sci 2011;16:44–50. |

| |Roberto Rossi, Davide E Bonasio, Annuziato Amendola. The Role of High Tibial Osteotomy in Varus Knee. Journal of American Academy Of |

| |Orthopaedic Surgeons oct 2011;19(10):590-99. |

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| |Pietro Maniscalco. High Tibial Osteotomy with External Fixator in the Varus Gonarthritic Knee. Acta Bio Medica 2003;74:76-80. |

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| |M. Pfahler, C. Lutz, H. Anetzberger, M. Maier, J. Hausdorf, C. Pellengahr, H. J. Refior. Long-Term Results of High Tibial Osteotomy for |

| |Medial Osteoarthritis of the Knee. Acta chir belg 2003;103: 603-06. |

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| |Mark B. Coventry, Duane M. Ilstrup, Steven L. Wallrichs. Proximal tibial osteotomy. The Journal of Bone And Joint Surgery |

| |1993;75-A(2):196-201. |

| |Robert D. A. Gaasbeek, Loes Nicolaas, Willard J. Rijnberg, Corne J. M.Van Loon, Albert Van Kampen. Correction accuracy and collateral laxity |

| |in open versus closed wedge high tibial osteotomy. A one-year randomised controlled study. International Orthopaedics (SICOT) 2010; 34:201–07|

| |Annuziato Amendola, Davide Edardo Bonasia. Results of High tibial osteotomy: Review of Literature. International Orthopaedics(SICOT) |

| |2010;34:155-60. |

| |G F McCoy, H K Graham, C J McClelland. High tibial osteotomy in degenerate diseases of the knee. The Ulster Medical Journal 1985;54(1):46-52 |

| |Goran Magyar, Soren Toksvig-Larsen, Anders Lindstrand. Open wedge tibial osteotomy by callus distraction in gonarthrosis. Acta Orthop Scand|

| |1998;69(2):147-51. |

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| |Federico Dettoni, Davide Edorado Bonasia, Filippo Castoldi, Matteo Bruzzone, Davide Blonna, Roberto Rossi. High tibial osteotomy versus |

| |unicompartmental knee arthroplasty for Medial Compartment Arthrosis of the knee: A Review of the Literature. The Iowa orthopaedic Journal |

| |30:131-40. |

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| |Himanshu Kataria, Sardar singh. High tibial osteotomy for primary osteoarthritis of knee. Indian journal of orthopaedics 1995;29:32-35. |

| |Varun Chandra, Sanjay Panda. High tibial osteotomy in varus arthritic knee. Indian journal of orthopaedics 2001;35(4):217-19. |

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| 9 |Signature of the candidate | |

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| | |DR. RAVIRAJ TANTRY |

| 10. |Remarks of the guide | |

| | |RECOMMENDED |

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| | |Dr. CHIDENDRA M SHETTAR |

|11. |Name and Designation |PROFESSOR , |

| |11.1 Guide |DEPARTMENT OF ORTHOPAEDICS, |

| | |SDMCMSH, DHARWAD-580009. |

| |11.2 Signature | |

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| |11.3 Co-Guide | |

| |11.4 Signature | |

| |11.3 Head of the Department |Dr. CHANDRAKANT NALLULVAR, |

| | |PROFESSOR AND HEAD OF DEPARTMENT, |

| | |DEPARTMENT OF ORTHOPAEDICS, |

| | |SDMCMSH, DHARWAD-580009. |

| |11.4 Signature | |

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| 12. |12.1 Remarks of the Principal | |

| |and Chairman | |

| |12.2 Signature | |

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ANNEXURE-III

VOLUNTEER’S CONSENT FORM

|Principal investigator Co-investigator |

|DR RAVIRAJ TANTRY DR CHIDENDRA M SHETTAR |

|Post Graduate Student, Professor, |

|Department of Orthopedics, Department of orthopedics, |

|SDMCMS&H, Dharwad-09 SDMCMS&H, Dharwad-09 |

|STUDY-Medial opening wedge high tibial osteotomy with an orthofix external fixator for unicompartmental medial osteoarthritis of knee. |

This study has been explained to me and I understand what the study involves.

That I can refuse to permit carrying on with the any of the procedure said above.

Those above said procedure are to help my treatment and for the research purpose

The complications of the procedure like Pin tract infections, Non union, Deep vein Thrpmbosis and failure of he procedure etc have been explained to me .

I therefore agree to take part in the study.

Signature of the patient/parents ………………………………………………

Full name…………………………………………………………..

Date……………………..

Full address………………………………

……………………………….

………………………………..

ANNEXURE-I

PROFORMA FOR STUDY OF KNEE EXAMINATION

1. Sr.No :

2. Name

3. Age :

4. Sex : Male / Female

5. OP No. : I.P.No. :

6. Address:

7. Chief complaints:

8. History of presenting illness :

9. Date and Time of Hospital Admission:

10. Clinical examination:

1. Medial joint line

2. Range of movement

3. Angular deformity

4. Anterior drawer test

5. Posterior drawer test

6. Mcmurray’s test

11. Radiological findings- 1. Knee-anteroposterior view with full weight bearing

2. Knee-lateral view with full weight bearing

3. CT Scanogram – to assess the mechanical axis

12) Knee society score

13. Diagnostic arthroscopy-

KNEE SOCIETY SCORE

Patient's Name-

PART I

1) PAIN

|None | |

|Mild/Occasional | |

|Mild (Stairs Only) | |

|Mild (Walking and Stairs ) | |

|Moderate-Occasional | |

|Moderate-Continual | |

|Severe | |

2) TOTAL RANGE OF FLEXION (In Degrees)

| 0-5 | 6-10 |11-15 |16-20 | 21-25 |

| 26-30 | 31-35 |36-40 |41-45 | 46-50 |

| 51-55 | 56-60 |61-65 |66-70 | 71-75 |

| 76-80 | 81-85 |86-90 |91-95 | 96-100 |

| 101-105 | 106-110 | 111-115 | 116-120 | 121-125 |

3) FLEXION CONTRACTURE (If Present) (In Degrees)

|5-10 | |

|10-15 | |

|16-20 | |

|>20 | |

4) EXTENSION LAG(In Degrees)

|20 | |

5) ALIGNMENT (Varus and Valgus)(In Degrees)

|0 |1 |2 |3 |4 |5-10 |

|11 |12 |13 |14 |15 |>15 |

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6) STABILITY (Maximum Movement In Any Position)

| ANTERO-POSTERIOR | MEDIO-LATERAL(Degrees) |

|10 Blocks | |

|5-10 Blocks | |

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