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Clinical Trials/NCT04450485
NCT04450485CompletedNot Applicable

Does Mini Mid-Vastus Approach Have An Advantageous Effect On Rapid Recovery Protocols Over Medial Parapatellar Approach In Total Knee Arthroplasty? A Prospective, Randomized, Single-Blinded Study

Pamukkale University1 site in 1 country54 target enrollmentStarted: May 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
54
Locations
1
Primary Endpoint
Pain postoperative 1

Study Overview

Brief Summary

Nowadays, due to the demands to improve life and health conditions of osteoarthritis patients, more effective surgical treatment methods are needed to obtain satisfactory results when performing total knee arthroplasty (TKA). Fast-track surgical protocols are evidence based multidisciplinary approaches targeted on multimodal patient care and primarily focused on enhancing rapid functional recovery of the patients. These protocols recommend use of minimal invasive approaches for TKA patients to enhance rapid recovery. Although studies in the literature has been reported similar results in medial para-patellar approach (MPP) and minimal invasive approaches in long terms, better surgical outcomes in short term in favor of minimal invasive approaches also encouraged fast-track protocol builders to prefer minimal invasive approaches. However, this recommendation is not evidence based and there is no study comparing surgical outcomes between minimal invasive approaches and MPP approach in terms of pain, length of hospital stays and functional recovery in fast-track TKA patients. Therefore, we aimed to compare the effects of mini mid-vastus (MMV) and MPP approaches on postoperative clinical results (pain, quality of life, functional outcome, and length of hospital stay) in fast-track TKA patients, and to decide whether any additional achievements are obtained with MMV approach in this patient group.

Detailed Description

Nowadays, due to the demands to improve life and health conditions of OA patients, more effective surgical treatment methods are needed to obtain satisfactory results when performing total knee arthroplasty (TKA). Fast-track surgical protocols are evidence based multidisciplinary approaches targeted on multimodal patient care and primarily focused on enhancing rapid functional recovery of the patients. These protocols include patient education to cope with anxiety and stress of surgery, nutritional planning and avoidance of long hours of fasting, preemptive analgesia, avoidance of tourniquet use, rational antibiotic prophylaxis, local infiltration anesthesia, and early physical therapy modalities. The ultimate aims of assembling these surgical protocols are to decrease mortality and morbidity, length of hospital stay, and eventually hospital costs while obtaining maximum patient satisfaction.

Surgical approaches when performing TKA operations includes standard medial parapatellar (MPP) approach and minimal invasive approaches such as mini midvastus (MMV) and subvastus (SV) approaches. Possible advantages of not performing quadriceps tendon splitting in MV surgical approach (such as less pain, earlier functional recovery, enhanced quadriceps muscle strength, and better ROM) convinced surgeons to prefer minimal invasive approaches to MPP approach when performing rapid recovery protocols in TKA patients. In addition, better surgical outcomes with traditional protocols in short term reports in favor of minimal invasive approaches also encouraged fast-track protocol builders to prefer minimal invasive approaches. However, these recommendations are not evidence based and, to our knowledge, there is no study comparing surgical outcomes between minimal invasive approaches and MPP approach in terms of pain, length of hospital stay and functional recovery in fast-track TKA patients. Therefore, we aimed to compare the effects of MMV and MPP approaches on postoperative clinical results (pain, quality of life, functional outcome, and length of hospital stay) in fast-track TKA patients, and to decide whether any additional achievements are obtained with MMV approach in this patient group. Our secondary outcome measures were length of operation time, blood loss and postoperative component alignments.

Clinical and demographic variables of the participants were recorded and patients were evaluated preoperatively, at postoperative fourth and twelfth week by a blinded observer. Knee range of motion was assessed with digital goniometer (HALO Medical Devices, Australia); quadriceps muscle strength was measured (unit=newton(N)) with hand-held dynamometer (Commander Muscle Tester, J Tech, USA); The Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Knee injury and Osteoarthritis Outcome Score (KOOS) was used to determine patient-reported activity limitations; 30-sec chair-stand test and stair-climb test were performed for performance-based activity limitations; Short Form-36 (SF-36) was used for quality of life evaluations.

Alignment analysis Long leg radiographs of the patients were evaluated preoperatively and postoperatively by using a digital orthopedic templating software-Materialise OrthoView (OrthoView version 7, Materialise HQ, Technologielaan 15 3001 Leuven, Belgium). Hip-knee-ankle angles (HKA), femorotibial angles, lateral proximal femoral angles (LPFA), lateral distal femoral angles (LDFA), medial proximal tibial angles (MPTA), lateral distal tibial angles (LDTA), tibial posterior slope angles were all measured and recorded by a blinded observer.

Preoperative patient education classes All the patients were received preoperative informative classes about TKA procedure, nutritional and nursing support, physical therapy and rehabilitation applications. Booklets concerning all these classes were also handed out to all patients.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Patients and outcomes assessor are blinded to the type of surgical approach.

Eligibility Criteria

Ages
50 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients scheduled for unilateral TKA surgery due to primary OA
  • •Patients capable of understanding verbal and written instructions.

Exclusion Criteria

  • •Revision TKA surgery
  • •ASA score >3
  • •previous major orthopedic surgery in either lower extremities
  • •neurologic compromise
  • •psychiatric problems
  • •regular hypnotic and/or anxiolytic medication usage
  • •patients participated in a particular physical activity program within the last 3 months.

Arms & Interventions

Medial para-patellar approach

Active Comparator

Fast track protocol applied total knee arthroplasty patients operated by using medial para-patellar approach

Intervention: Total knee arthroplasty (Procedure)

Mini mid-vastus approach

Active Comparator

Fast track protocol applied total knee arthroplasty patients operated by using mini mid-vastus approach

Intervention: Total knee arthroplasty (Procedure)

Outcomes

Primary Outcomes

Pain postoperative 1

Time Frame: at postoperative fourth weeks

Visual Analog Scale used to assess pain

Pain postoperative 2

Time Frame: at postoperative twelfth weeks

Visual Analog Scale used to assess pain

Quality of life-preoperative- postoperative 1

Time Frame: at postoperative fourth weeks

Short Form-36 (SF-36) is used

Quality of life-preoperative- postoperative 2

Time Frame: at postoperative twelfth weeks

Short Form-36 (SF-36) is used

Length of hospital stay

Time Frame: through study completion, an average of 1 year

Length of hospital stay is measured beginning from the hospitalization of the patient and ending at discharge of the patients (unit-hours)

Quadriceps muscle strength postoperative 1

Time Frame: at postoperative fourth weeks

Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer (Commander Muscle Tester, J Tech, USA)

Quadriceps muscle strength postoperative 2

Time Frame: at postoperative twelfth weeks

Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer (Commander Muscle Tester, J Tech, USA)

Patient-reported activity limitations preoperative

Time Frame: Baseline (preoperatively)

The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used

Patient-reported activity limitations postoperative 1

Time Frame: at postoperative fourth weeks

The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used

Patient-reported activity limitations postoperative 2

Time Frame: at postoperative twelfth weeks

The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used

Performance-based activity limitations-preoperative

Time Frame: Baseline (preoperatively)

30-sec chair-stand test and stair-climb test are used

Pain preoperative

Time Frame: Baseline (preoperatively)

Visual Analog Scale used to assess pain

Knee Range of Motion preoperative

Time Frame: Baseline (preoperatively)

Digital goniometer (HALO Medical Devices, Australia) used to assess knee range of motion

Knee Range of Motion postoperative 1

Time Frame: at postoperative fourth week

Digital goniometer (HALO Medical Devices, Australia) used to assess knee range of motion

Knee Range of Motion postoperative 2

Time Frame: at postoperative twelfth week

Digital goniometer (HALO Medical Devices, Australia) used to assess knee range of motion

Quadriceps muscle strength preoperative

Time Frame: Baseline (preoperatively)

Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer (Commander Muscle Tester, J Tech, USA)

Performance-based activity limitations- postoperative 1

Time Frame: at postoperative fourth weeks

30-sec chair-stand test and stair-climb test are used

Performance-based activity limitations - postoperative 2

Time Frame: at postoperative twelfth weeks

30-sec chair-stand test and stair-climb test are used

Quality of life-preoperative

Time Frame: Baseline (preoperatively)

Short Form-36 (SF-36) is used

Secondary Outcomes

  • Length of operation time(the surgery)
  • Amount of blood loss(through study completion, an average of 1 year)
  • postoperative component alignments(through study completion, an average of 1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Harun Resit Gungor

MD, Associated Professor

Pamukkale University

Study Sites (1)

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