Author, Year | Implant | Study design | N | Demographics Mean (±SD) or (range), unless otherwise specified | Results Mean (±SD) or (range) unless otherwise specified VAS uses a 0-10 scale unless otherwise specified | Complications (n) |
---|---|---|---|---|---|---|
Whang, 201539 | Triangular TPS coated implants | Prospective, multi-center, randomized controlled trial (surgical arm reported herein) | 102 | Age: 50.2 (26-72) years Sex: 75 F/M Prior lumbar fusion: 38% Follow-up: 6mo | VAS: 8.2 (1.2) pre-op, 2.9 (2.9) at 6mo ODI: 62.2 (14.5) pre-op, 31.9 (22.7) at 6mo SF-36PCS: 30.2(6.2) pre-op, 42.8 (10.0) at 6mo Surgical time: 44.9 (22.3) min EBL: 32.7 (32.8) mL Hospital stay: 0.8 (range 0-7) days | Trochanteric bursitis (4), surgical wound problems (4), iliac fracture (1), hairline ilium fracture (1), nerve root impingement (1) |
Vanaclocha 201449 | Triangular TPS coated implants | Single center case series | 24 | Age: 47.4 (32-71) years Sex: 15F/9M Prior lumbar fusion: 2 Follow-up: 23mo (1-4.5 years) | VAS: 8.7 pre-op, 1.7 at 1yr, 2.1 at 4.5yrs ODI: 54.1 pre-op, 14.3 at 1yr, 16.3 at 4.5yrs Surgical time: 48 (40-65)min, unilateral cases EBL: 58 (40-70)mL | Immediate post-op pain (4-resolved), temporary post-op radiculopathic pain (2) |
Rudolf, 201438 | Triangular TPS coated implants | Single center case series | 17 | Age: 58 (36-85) years Sex: 13F/4M Prior lumbar fusion: 8 (47%) Follow-up: 60mo Bridging bone: 87% (13/15) | VAS: 8.3 (1.4) pre-op, 3.4 (2.4) at 1yr, 1.4 (2.6) at 2yrs, 2.4 (2.2) at 5yrs ODI: 21.5 (22.7) at 5yrs Surgical time: 65 (18) min | No intraoperative complications, hematoma (1), cellulitis (2), deep wound infection secondary to diverticulitis (1) |
Sachs, 201450 | Triangular TPS coated implants | Multi-center, Retrospective | 144 | Age: 58 (30-89)years Sex: 30F/10M Prior lumbar fusion: 62% Follow-up: 16mo (12-26) | VAS: 8.6 pre-op, 2.7 at follow-up 91% Very or somewhat satisfied 91.7% would have surgery again Surgical time: 73min EBL: 31mL Hospital stay: 0.8 days | No intraoperative complications. fall (5), trochanteric bursitis (4), piriformis syndrome (3), facet pain (3), contralateral SIJ pain(2), recurrent pain (3), leg pain (1), toe/foot numbness (2), hematoma (1), low back pain (1), implant revision (1),burning in upper thigh (1), bladder incontinence (1) |
Ledonio,201427 | Triangular TPS coated implants | Single center Retrospective, comparative cohort study | 22 | MIS Cohort Age: 47.9 (13.1) years Sex: 17F/5M Prior lumbar fusion: 64% Follow-up: median 15mo (12-26) | ODI: 61.5 (12.5) pre-op, 52 (16.9) at follow-up Surgical time: 68.3(26.8) min EBL: 40.5 (31.4) mL Hospital Stay: 2.0 (1.5) days | Pulmonary embolism that resolved with treatment (1), revisions due to halo formation on the sacral side with recurring sacroiliac joint pain (2) |
4.5mm plate, autograft | 22 | Open Cohort Age: 51 (9.4) years Sex:13F/9M Prior lumbar fusion: 50% Follow-up: median 13(11-33) mo | ODI: 61.8 (10.8) pre-op, 47.4 (21.7) at follow-up Surgical time: 128 (27.9) min EBL: 168.8 (479.0) mL Hospital Stay: 3.3 (1.1) days | Pulmonary embolism (1), revision due to failed implant and nerve root irritation (2) | ||
Ledonio 201428 | Triangular TPS coated implants | Multi-center Retrospective, comparative cohort study | 17 | MIS Cohort Age: median 66 (39-82) years Sex: 11F/6M Prior lumbar fusion: 82% Follow-up: 12mo | Values reported as median (range) ODI: 53 (14-84) pre-op, 13 (0-38) at 12 mo Surgical time: 27 (18-72) min Hospital Stay: 1 (1-2) days | Transient trochanteric bursitis (3), hematoma (1), transient toe numbness (1), revision due to malpositioned implant (1) |
4.5mm plate, autograft | 22 | Open Cohort Age: median 51 (34-74) years Sex: 82F/32M Prior lumbar fusion: 47% Follow-up: 24mo | Values reported as median (range) ODI: 64 (44-78) pre-op, 46 (10-80) at 12 mo Surgical time: 128 (73-180) min Hospital Stay: 3 (2-6) days | Pulmonary embolism (1), revision due to failed implant and nerve root irritation (2) | ||
Graham-Smith, 201326 | Triangular TPS coated implants | Multi-center Retrospective comparative cohort study | 114 | MIS Cohort Age: 57.4 (14.0) years Sex: 82F/32M Prior lumbar fusion: 47.4% Follow-up: 24mo | VAS: 8.3 (1.6) pre-op, 2.3 (2.6) at 12mo, 1.7 (2.9) at 24mo MCID: 86% reached at 12mo, 82% at 24mo Surgical time: 70 (24) min EBL: 33 (27) mL Hospital stay: 1.3 (0.5) days | No intraoperative complications. Postop repositioning of implants (4), 3.5% (4/114), cellulitis (3), facet pain (4) piriformis syndrome (2), trochanteric bursitis (2), wound infection (1) |
Screws, plates | 149 | Open Cohort Age: 45.8 (11.3) years Sex: 103F/46M Prior lumbar fusion: 23.5% Follow-up: 24mo | VAS: 7.1 (1.9) pre-op, 4.6 (3.0) at 12mo, 5.6 (2.9) at 24mo MCID: 61% reached at 12mo, 50% at 24mo Surgical time: 163 (25) min EBL: 288 (182) mL Hospital stay: 5.1 (1.9) days | No intraoperative. Postop removal of implants (66), 44% (66/149). Bone fragment (1), cellulitis (1), leg pain (3), postoperative neuropathy (4), pulmonary embolism (2), trochanteric bursitis (4), wound infection (3) | ||
Duhon, 201324 | Triangular TPS coated implants | Multi-center, Prospective, efficacy (32) and safety (94) cohorts | 32, 94 | Age: 50.2 (12.6) years Sex: 21F/11M Prior lumbar fusion: 69% Follow-up: 6mo | VAS (0-100mm): 76.2 (16.2) pre-op, 29.3 (23.3) at 6mo ODI: 55.3 (10.7) pre-op, 38.9 (18.5) at 6mo SF-36 PCS: 30.7 (4.3) pre-op, 37 (10.7) at 6mo 88.5% (23/26) success rate Surgical time: 48 (16.1) min EBL: 59 (95) mL Hospital stay: 0.8 days | No implant revision or removal, 6 AEs probably or definitely procedure-related (2 nausea, 2 wound infections, 1 cellulitis, 1 buttock pain) |
Sachs, 201344 | Triangular TPS coated implants | Single center, Retrospective case series | 40 | Age: 58 (30-81) years Sex: 30F/10M Prior lumbar fusion: 30% Follow-up: 12mo | VAS: 8.7 (1.5) pre-op, 0.9 (1.6) at 12mo 98% reached MCID 100% patient satisfaction | Piriformis syndrome (1), new LBP (1), facet joint pain (8), trochanteric bursitis (2) |
Cummings, 201345 | Triangular TPS coated implants | Single center, Retrospective case series | 18 | Age: 64 (39-81) years Sex: 12F/6M Prior lumbar fusion: 61% Follow-up: 12mo | VAS: 8.9 (1.9) pre-op, 2.3(2.1) at 12mo 90% reached MCID ODI: 52.6 (18.8) pre-op, 13.2 (12.6) at 12mo SF-12 PCS: 37.8 (10.4) pre-op, 44.6 (10.5) at 12mo | Trochanteric bursitis (3), hematoma (1), fluid retention (1), toe numbness (1), implant malposition (1) |
Gaetani, 201335 | Triangular TPS coated implants | Single center, Retrospective case series | 12 | Age: 53.2 (36-71) years Sex: 12F Prior lumbar fusion: 8.3% Follow-up: 10mo (8-18) | VAS: 7.7 (1.3) pre-op, 3 (1.2) at follow-up ODI: 31.4 (6.3) pre-op, 12 (3.5) at follow-up RDQ: 17.6 (1 pre-op, 3 (4.1) at follow-up Surgical time: 65 (16) min EBL: <45 mL 3 month CT scans show initial fusion | Local hematoma (2), low back pain (1) |
Schroeder, 201334 | Triangular TPS coated implants | Single center, Retrospective case series | 6 | Age: 50 (25-60) years Sex: 6F/0M Prior lumbar fusion: 100% (deformity correction) Follow-up: 10.25mo (4-15) | VAS: 7.83 pre-op, 2.67 at follow-up ODI: 22.1 pre-op, 10.5 at follow-up Hospital stay: 2 days (range 1-4) Bony bridging seen in 4 patients | No intraoperative or post-operative complications. |
Rudolf, 201346 | Triangular TPS coated implants | Single center, Sub-group analysis | 40 | *Subgroup analysis from Rudolf 2012 to assess effect of prior lumbar fusion on outcomes. Follow up: 12 and 24 months | ||
18 | *No prior fusion Age: 49(12) Sex: 12F/6M | VAS decrease at 12mo: -5.94 (3.3) VAS decrease at 24mo: -5.47 (2.88) Surgical time: 60(19) min | Superficial cellulitis (2), wound infection (1), revision for implant malposition (1) | |||
15 | *Prior lumbar spinal fusion Age: 58(11) Sex: 11F/4M | VAS decrease at 12mo: -3.5 (3.46) VAS decrease at 24mo: -5.81 (3.5) Surgical time: 64(19) min | Superficial cellulitis (2), buttock hematoma (1), revision for implant malposition (1) | |||
7 | *Concomitant lumbar pathology treated non-surgically Age: 58(17) Sex: 3F/4M | VAS decrease at 12mo: -3.71 (3.11) VAS decrease at 24mo: -4.79 (4.28) Surgical time: 64(19) min | None reported | |||
Rudolf, 201247 | Triangular TPS coated implants | Single center, Retrospective case series | 50 | Age: 54 (24-85) years Sex: 34F/16M Prior lumbar fusion: 44% Follow-up: 40mo (24-56) | VAS: 7.6 pre-op, 2.0 at follow-up 82% reached MCID 82% patient satisfaction Surgical time: 65 (26) min | superficial cellulitis (3), deep wound infection (1), hematoma (2), reoperation (3) |
Sachs, 201248 | Triangular TPS coated implants | Single center, Retrospective case series | 11 | Age: 65 (45-82) years Sex: 10F/1M Prior lumbar fusion: 18% Follow-up: 12mo | VAS: 7.9 (2.2) pre-op, 2.3 (3.1) at 12mo Surgical time: 77.5 (31.8) min EBL: 21.8 (18.9) mL | Piriformis syndrome (1), low back pain (1) |
Mason, 201336 | HMA screw packed with DBM | Prospective case series | 55 | Age: 57 years Sex: 46F/9M Prior lumbar fusion: 40% Follow-up: 36 (12-84) mo | VAS: 8.05 (1.9) pre-op, 4.48 (2.81) at follow-up SF-36PCS: 26.6 (15.2) pre-op, 43 (22.68) follow-up Majeed: 36.18 (15.08) pre-op, 64.78 (20.18) follow-up | Post-op nerve pain requiring reoperation (2) |
Khurana, 200937 | HMA screw packed with DBM | Retrospective case series | 15 | Age: 48.7 (37.3-62.6) years Sex: 11F/4M Prior lumbar fusion: 40% Follow-up: 17 (9-39) mo | SF-36PCS: 28.49 (11.24) pre-op, 51.38 (9.87) at follow-up Majeed: 37 (18-54) pre-op, 79 (63-96) at follow-up Good to excellent results: 13/15 EBL: < 50 ml Hospital stay: 2.7 (1-7) days | No post-operative neurological or wound complications. |
Al-Khayer, 200812 | HMA screw packed with DBM | Retrospective case series | 9 | Age: 42 (35-56) years Sex: 9F Follow-up: 40 (24-70) mo | VAS: 8.1 (7-9) pre-op, 4.6 (3-7) follow-up ODI: 59 (34-70) to 45 (28-60) EBL: <50 ml Hospital stay: 6.9 (2-11) days Return to work: 44.44% | Deep wound infection requiring debridement and IV antibiotics (1) |
Abbreviations: F: female; M: male; EBL: estimated blood loss; mo: month; ODI: Oswestry Disability Index; VAS: Visual Analog Scale; DBM: demineralized bone matrix; HMA: hollow modular anchorage; BMP: bone morphogenic protein.