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| Name | Class |
|---|---|
| Stryker Instruments | INDUSTRY |
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The overall aim of this single-centre, prospective randomised controlled trial is to compare clinical, functional, and radiological outcomes in CO THA versus Mako THA. Patients undergoing Mako THA will form the investigation group and those undergoing CO THA will form the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CO THA | Active Comparator | Computerised tomography based planning of conventional total hip arthroplasty |
|
| Mako THA | Experimental | Mako robotic-arm assisted total hip arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CO THA | Device | Replacement of arthritic hip with artificial implant using CT-based navigation and conventional technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reproducibility of the planned pre-operative centre of rotation [COR] of the hip | Radiographic assessment of the COR will be performed using coronal plane images from the preoperative pelvic CT scan and postoperative CT scanogram at six weeks after surgery. The COR will be determined using the centre of a circle encompassing the native femoral head on the contralateral side in the preoperative films and the prosthetic femoral head on the ipsilateral side on postoperative films. The horizontal COR will be calculated by measuring the distance between the COR and a line running directly perpendicular from the midline of the pelvis, which is defined as a line connecting the middle of the pubic symphysis and the middle of the inter-sacroiliac line. The vertical COR will be calculated by measuring the distance of a line that runs directly perpendicular from the inter-tear drop line to the COR. | 6 weeks post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Spinopelvic alignment | Spinopelvic alignment with plain radiographs in sitting and standing position;
| Preoperatively and postoperatively at 6 months |
| Operating time |
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Inclusion Criteria:
Patient has hip osteoarthritis requiring primary THA
Exclusion Criteria:
Patient is not suitable for primary THA e.g. patient requires revision surgery for previously failed THA
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| Name | Affiliation | Role |
|---|---|---|
| Fares S Haddad | UCL Hospital NHS Foundation Trust | Study Chair |
| Babar Kayani | UCL Hospitals NHS Foundation TRust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCL Hospital NHS Foundation Trust | London | NW1 2BU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32912292 | Derived | Kayani B, Konan S, Tahmassebi J, Ayuob A, Haddad FS. Computerised tomography-based planning with conventional total hip arthroplasty versus robotic-arm assisted total hip arthroplasty: study protocol for a prospective randomised controlled trial. Trials. 2020 Sep 10;21(1):776. doi: 10.1186/s13063-020-04702-7. |
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No plans to share IPD
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Mako THA | Device | Replacement of arthritic hip with artificial implant using mako robotic-arm assist |
|
Length of operating time in minutes |
| Intraoperative |
| Blood loss | Estimated intraoperative blood loss in millilitres [ml] | Intraoperative |
| Blood transfusion requirements | Units of blood required for transfusion intraoperatively; in whole units | Intraoperative |
| Bone resection thickness | Thickness of bone resected during the surgical procedure in millimetres | Intraoperative |
| Length of hospital stay | Length of patient hospital stay from admission to documented discharge; hours | 6 weeks post op |
| Oxford hip score [OHS] | Patient recorded outcome measure via questionnaire. Scored 0-48 with 0 = poor score and 48 = best possible score | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op |
| Harris Hip Score [HHS] | Patient recorded outcome measure via questionnaire. Scored 0-100 with 100 best possible outcome | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op |
| Western Ontario and Mcmaster Universities Osteoarthritis Index [WOMAC] | Patient recorded outcome measure via questionnaire. Questions regarding pain, stiffness and disability of affected hip joint. 0= best possible score | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op |
| University of California at Los Angeles hip [UCLA] | Patient recorded outcome measure via questionnaire. Score 0-10 with 10 being best possible outcome, 0 being worst possible outcome | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op |
| European Quality of Life questionnaire with 5 dimensions for adults [EQ-5D] | Health-related quality of life patient recorded outcome measure via questionnaire. Score 0-1 with 1 being best possible outcome and 0 being worst possible outcome | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op |
| Complications | Complications relating to surgery; to include development of: leg-length inequality in millimetres; deep venous thrombosis; fracture; dislocation of the prosthesis; neurovascular injury; infection of wound; deep infection involving prosthesis; re-operation or revision surgery; pulmonary embolus; heart attack; stroke; death | Intraoperative; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op |